In the News

New Study: Vitamin K2 is Shown to Impact Cardiovascular Health

Landmark Study of Nearly 350,000 Patients Finds Expanded Prenatal Genetic Testing Could Increase Detection of Risk for Serious Inherited Diseases

New LAMA I Study: Lutemax 2020 Demonstrates Enhanced Bioavailability

Fluoride Consumption Linked to Diabetes Using Mathematical Models

American College of Healthcare Sciences Hires Denise Dallmann to Serve as Academic Dean

New Treatment for Low Back Pain: Minimally Invasive Procedure Receives FDA Clearance

New Study Published on the "Effect of Oral Re-Esterified Omega-3 Nutritional Supplementation on Dry Eyes"

From the Alzheimer's Association International Conference 2016: A 6-Year Trial with a Vascular Care Intervention to Prevent Dementia

New Study: Vitamin K2 is Shown to Impact Cardiovascular Health

Atherosclerosis has published a new long-term study that explores if there is a relationship between intake of phylloquinone and menaquinones (vitamins K1 and K2, respectively) and risk of peripheral arterial disease (PAD). The results showed that high intake of menaquinones (vitamin K2) was associated with a reduced risk of PAD (at least in hypertensive participants), while high intake of phylloquinone (vitamin K1) was not associated with a reduced risk of PAD. PAD is similar to coronary artery disease (CAD) in that respect that both are caused by atherosclerosis that narrows and blocks arteries in various critical regions of the body.

“Like the Rotterdam Study (2004) and Prospect-EPIC Study (2009), the cardiovascular benefits of K vitamins are only recognized with vitamin K2, not vitamin K1,” says Hogne Vik, chief medical officer with NattoPharma, world leader in vitamin K2 R&D and exclusive global supplier of MenaQ7® Vitamin K2 as MK-7. “This is important because there is a misconception that daily recommended intake (RDI) of the vitamin K1 is sufficient to protect the arteries for developing arterial diseases.  This is not the case, since vitamin K1 is only documented and recognized to meet our needs for coagulation. It is, however, vitamin K2, the menaquinones, that are responsible for the cardiovascular benefits, and not vitamin K1.”

A low vitamin K status, as indicated by high dephosphoundercarboxylated MGP (duc-MGP) levels, has been associated with an increased risk of PAD among type 2 diabetes patients in previous research. To explore a possible clinical applicability for the relationship between low vitamin K status and PAD, the authors aimed to investigate the relationship between dietary intake of phylloquinone and menaquinones and risks of PAD. Furthermore, they examined this association in a general population and explored effects of modification through cardiovascular risk factors such as sex, hypertension, and diabetes.

The study, “The relationship between vitamin K and peripheral arterial disease,” followed up with 36,629 men and women over 12.1 years. During that time, 489 incident cases of PAD were documented. Menaquinones intake was associated with a reduced risk of PAD with a hazard ratio (HR) of 0.71, 95% CI; 0.53-0.95 for the highest versus lowest quartile.

According to the researchers, a stronger association was observed (p interaction 0.0001) in study participants with hypertension (HRQ4 versus Q1 0.59; 95% CI 0.39-0.87) or diabetes (HRQ4 versus Q1 0.56; 95% CI 0.18-1.91), though confidence intervals were wide in the small (n = 530) diabetes stratum. Phylloquinone intake (vitamin K1) was not associated with PAD risk.

The researchers concluded: “A high intake of menaquinones (vitamin K2) was significantly associated with a reduced risk of PAD, at least in hypertensive participants. A high menaquinone intake may be associated with a reduced risk of PAD in participants with diabetes as well, though no statistically significant results were observed. High phylloquinone intake (vitamin K1) does not seem associated with PAD risk.”

“Based on our three-year interventional study², it was shown that adding vitamin K2 to one’s daily intake

improves arterial health and flexibility,” Vik adds. “We are excited and thankful to see additional studies confirming this mechanism and encourage the nutritional community to embrace vitamin K2 for its unique and specific benefits.”

To view the new study in Atherosclerosis, visit: http://www.atherosclerosis-journal.com/article/S0021-9150(16)31216-3/abstract.

Landmark Study of Nearly 350,000 Patients Finds Expanded Prenatal Genetic Testing Could Increase Detection of Risk for Serious Inherited Diseases

Counsyl, a DNA testing and genetic counseling service, today announced a new study published in the Journal of the American Medical Association (JAMA), which concludes that expanded carrier screening (ECS) may significantly increase the detection of carrier status for severe genetic conditions as compared to current screening guidelines.

In a joint statement issued last year, several medical societies requested further research to better quantify the clinical impact of ECS across ethnic groups. This study answers that call, and provides important new data to support the further examination and potential adaptation of screening guidelines.

The study, titled “Modeled Fetal Risk of Genetic Diseases Identified by Expanded Carrier Screening,” examined DNA test results of nearly 350,000 individuals, spanning 15 ethnicities, to assess the prevalence of genetic variants associated with 94 severe or profound inherited genetic conditions. Severe conditions are defined as causing intellectual disability or a substantially shortened lifespan; profound conditions cause both.

Current guidelines, which typically recommend testing for a small number of conditions in patients of select ethnicities, are tailored to those of a particular ethnic background or those with a family history. Broader implementation of ECS is now possible because of advanced technology, and the study shows that ECS could benefit today’s diverse population.

“Even though the guidelines target a number of diseases prevalent in those of European descent (such as cystic fibrosis), they do not identify risk for other conditions that may be important to diverse populations. Expanded carrier screening revealed that many non-European racial/ethnic categories have a risk of profound or severe genetic disease that may not be detected by the guidelines in place at this time of analysis,” the authors write.

Data in the study demonstrates that across ethnic groups, a significant percentage of pregnancies affected by serious conditions may not have been detected under current screening guidelines set by the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics and Genomics (ACMG).

When results of the study are calculated in aggregate and weighted by US census demographics, approximately one in 550 pregnancies would be affected by a serious condition on the Family Prep Screen (the expanded carrier screen used in the study). This is comparatively higher than the known incidence of routinely screened-for conditions such as Down Syndrome, which has an incidence of one in 700 births.

“This research quantifies the clinical impact of expanded carrier screening, and demonstrates a significant opportunity to identify more pregnancies affected by serious genetic conditions,” said Imran Haque, PhD, VP, Scientific Affairs at Counsyl and lead author on the study. “Counsyl is committed to sharing insights with the scientific and medical communities based on our clinical experience of over half a million carrier screens. We hope this will drive forward the conversation on broader integration of screening for patients of all ethnicities.”

Authors of the study include Imran Haque, PhD, Gabriel Lazarin, MS, Peter Kang, MD, Eric Evans, PhD, James Goldberg, MD (Departments of Medical Affairs and Research, Counsyl), and Ronald Wapner, MD (Division of Reproductive Genetics, Department of Obstetrics and Gynecology, Columbia University Medical Center).

The study can be accessed here: Modeled Fetal Risk of Genetic Diseases Identified by Expanded Carrier Screening

For more information, visit www.counsyl.com.

New LAMA I Study: Lutemax 2020 Demonstrates Enhanced Bioavailability

Lutemax 2020 was shown to have proven bioavailability in a recent study conducted at the University of Georgia entitled LAMA I—an acronym for Lutein, Vision, and Mental Acuity. The findings of LAMA I were the subject of a paper, “Bioavailability of Lutein/Zeaxanthin Isomers and Macular Pigment Optical Density Response to Macular Carotenoid Supplementation: A Randomized Double Blind Placebo Controlled Study,” which was published in the journal New Frontiers in Ophthalmology, 2016.

“We strive to support the industry with scientifically-sound, clinically-supported ingredients tested in healthy populations by using some of the most trusted methods and measures,” said Vijaya Juturu, PhD, Sr. Scientific & Clinical Affairs Director (Global), OmniActive Health Technologies. “We chose to measure bioavailability using area under the plasma concentration curve (AUC) because it accurately represents the total amount of unchanged active compounds that reach systemic circulation. The results demonstrate the proven bioavailability of Lutemax 2020 at all three tested doses.”

For 12-weeks, 28 healthy subjects were randomly assigned to one of four groups: placebo, 6 mg L/1.26 mg Zi, 10mg L/2 Zi, or 20 mg L/4 mg Zi. Blood samples were collected at baseline and every two weeks thereafter (in a dose-dependent manner). Supplementation with Lutemax 2020 significantly increased serum AUC levels of lutein and zeaxanthin isomers. The findings also suggest that the high bioavailability of lutein and zeaxanthin isomers from Lutemax 2020 is due, in part, to this unique formula that contains all three macular carotenoids—lutein, RR-zeaxanthin, and RS (meso)-zeaxanthin.

LAMA I is one of numerous studies slated to come out of OmniActive’s robust clinical program.

“If I had to give insight into what the industry is going to see this year from OmniActive, I would sum it up in one word: science,” said Abhijit Bhattacharya, President, OmniActive Health Technologies Ltd. “With a 5:1 balanced lutein:zeaxanthin isomer ratio manufactured from a vertically-integrated source, Lutemax 2020 has always been a popular and differentiated ingredient. LAMA I is one study in a series of soon-to-be-released research that further supports the uniqueness of Lutemax 2020 in the marketplace.”

For more information on Lutemax 2020, OmniActive’s ingredients, or science, please contact Lynda Doyle at l.doyle@omniactives.com.

LUTEMAX 2020 is a trademark of OmniActive Health Technologies Ltd.

Fluoride Consumption Linked to Diabetes Using Mathematical Models

Water fluoridation prevents dental cavities, which are a costly public health concern. But despite the benefits, supplemental water fluoridation remains a controversial subject. Some indicate it may cause long-term health problems, but studies reporting side effects have been minimal or inconclusive. The long-term effects of ingested fluoride remain unclear.

A recent study published in the Journal of Water and Health examined links between water fluoridation and diabetes. Type 2 diabetes is a growing epidemic in the United States. Incidence rates have nearly quadrupled in the past 32 years and show no signs of stopping. According to the study, fluoridation with sodium fluoride could be a contributing factor to diabetes rates in the United States, as the chemical is a known preservative of blood glucose.

The sole author of the paper, Kyle Fluegge, PhD, performed the study as a post-doctoral fellow in the Department of Epidemiology and Biostatistics at Case Western Reserve University School of Medicine. Fluegge now serves as health economist in the Division of Disease Control for the New York City Department of Health and Mental Hygiene and co-director of the Institute of Health and Environmental Research in Cleveland, Ohio.

In the study, Fluegge used mathematical models to analyze publicly available data on fluoride water levels and diabetes incidence and prevalence rates across 22 states. He also included adjustments for obesity and physical inactivity collected from national telephone surveys to help rule out confounding factors. Two sets of regression analyses suggested that supplemental water fluoridation was significantly associated with increases in diabetes between 2005 and 2010.

“The models look at the outcomes of [diabetes] incidence and prevalence being predicted by both natural and added fluoride,” said Fluegge.

Fluegge reported that a one milligram increase in average county fluoride levels predicted a 0.17-percent increase in age-adjusted diabetes prevalence. Digging deeper revealed differences between the types of fluoride additives used by each region. The additives linked to diabetes in the analyses included sodium fluoride and sodium fluorosilicate. Fluorosilicic acid seemed to have an opposing effect and was associated with decreases in diabetes incidence and prevalence. Counties that relied on naturally occurring fluoride in their water and did not supplement with fluoride additives also had lower diabetes rates.

The positive association between fluoridation and diabetes was discovered when Fluegge adjusted fluoride exposure levels to account for estimated per capita tap water consumption.

“The models present an interesting conclusion that the association of water fluoridation to diabetes outcomes depends on the adjusted per capita consumption of tap water,” explained Fluegge. “Only using the concentration [of added fluoride] does not produce a similarly robust, consistent association.” For this reason, Fluegge adjusted his calculations to incorporate tap water consumption, instead of sticking to calculations that rely on “parts per million” measurements of fluoride in the water.

Fluegge used several estimations in his study, including calculations of county-level water fluoride levels; per capita county tap water consumption; and county measures of poverty, obesity, and physical inactivity. Although he doesn’t suggest the study should trigger policy changes, he does indicate it should serve as a call for additional research on the important association between fluoridation and diabetes.

“This is an ecological study. This means it is not appropriate to apply these findings directly to individuals,” explained Fluegge. “These are population-level associations being made in the context of an exploratory inquiry. And water is not the only direct source of fluoride; there are many other food sources produced with fluoridated water.”

In addition to being found in food like processed beverages or produce exposed to specific pesticides, fluoride is found naturally in water in the form of calcium fluoride. Supplemental fluoride was first added to community water supplies in the 1940s.

Said Fluegge, “The models indicate that natural environmental fluoride has a protective effect from diabetes. Unfortunately, natural fluoride is not universally present in the water supply.”

Residents can learn more about fluoride levels in their communities through the Centers for Disease Control My Water’s Fluoride database.

This work was supported by a National Institutes of Health National Heart Lung and Blood Institute (NIH NHLBI) training grant T32HL007567.

For more information about Case Western Reserve University School of Medicine, please visit http://case.edu/medicine.

SOURCE Case Western Reserve University

American College of Healthcare Sciences Hires Denise Dallmann to Serve as Academic Dean

American College of Healthcare Sciences (ACHS) announces that Denise Dallmann, ND, MS, has joined their team as Academic Dean. ACHS, administratively based in Portland, Oregon, is an accredited college specializing in undergraduate- and graduate-level holistic health and wellness degrees and certificate programs.

“I am honored to join such a progressive college that has been at the forefront of distance and holistic health education for almost 40 years,” says Dallmann. “I’m especially looking forward to working with President Dorene Peterson, Chief Strategy Officer Erika Yigzaw, and the school’s talented executive team, faculty, staff, and students in advancing our academic mission, working on new program development, providing support to our faculty, and helping our students achieve their academic goals.”

As Academic Dean, Dallmann will serve as the Chief Academic Officer for the institution and collaborate with the institution’s Board of Directors, President, Curriculum Committee, and other stakeholders to support academic integrity, curriculum development, and student retention.

Dallmann will also support the institution’s mission—to provide leadership in holistic health education through comprehensive professional online and on-campus education—through innovative project management in the implementation of new instructional technology; faculty recruitment, development, and retention; library services; and staff development.

Dallmann has more than 15 years’ experience in higher education and formerly served as director and associate dean for the National University of Natural Medicine (NUNM) and dean of academic affairs for Carrington College. She has been honored with several awards including the DeVry PRIDE award in recognition of her dedication, integrity, and excellence, a distinction reserved for the top 3% of DeVry’s 90,000 employees.

“Denise is amazing and we are super excited to have her join our academic team,” says Erika Yigzaw, ACHS CSO. “As a former naturopath and educator, she has a lot of experience in higher education administration, as well as considerable subject matter expertise to share. With our student-centric emphasis, we’re on the same wavelength and have already been making great progress on some of the exciting projects we are working on here at ACHS, including new courses in spa management and new student tools.”

Dallmann holds a doctorate in naturopathic medicine from NUNM, a master’s degree in educational leadership and policy from Portland State University (PSU), and a graduate certificate in student affairs in higher education from PSU. Her master’s thesis explored methods to develop high-quality and cost-effective undergraduate online programs.

For more information about the role of Academic Dean at ACHS or future program development, or to schedule an interview, call 800.487.8839 or email publicrelations@achs.edu. Learn more about current ACHS health and wellness programs at www.achs.edu.

New Treatment for Low Back Pain: Minimally Invasive Procedure Receives FDA Clearance

Back pain—it's the most common reason people go to their doctors. According to the National Institutes of Health, 80 percent of adults will experience low back pain some time in their lives. In fact, chronic low back pain, lasting 12 weeks or longer, affects nearly one-third of the nation's population.

Laura Donlon, 48, of Monroe had been dealing with low back pain for five years before she found out about a back pain study at Beaumont Hospital in Royal Oak, Michigan. The flight attendant says her pain was unbearable at times, especially when sitting. Seeking relief from her pain, caused by a degenerative disc, she contacted the orthopedic research team at Beaumont for details.

Treatments for low back pain range from noninvasive to invasive: physical therapy and pain medications to major surgery, such as spinal fusion. Now a minimally invasive, nerve ablating procedure, recently cleared by the Food and Drug Administration, may give some people with chronic low back pain a new treatment option.

"In 25 years of practicing orthopedics, this is the most important clinical study I've ever done," said Jeffrey Fischgrund, MD, chairman, Orthopedics, Beaumont Hospital, Royal Oak and principal investigator of the FDA-approved Relievant SMART trial. "The system is proven to be safe and effective in clinical trials. It is much less invasive than typical surgical procedures to treat low back pain."

A spine expert and orthopedic surgeon, Dr. Fischgrund helped design the research study. Research teams in the United States and Germany recruited 225 participants, with 150 receiving the minimally invasive, ablation treatment and 75 receiving the placebo.

Donlon was told she met the trial criteria and enrolled in the study. In December 2014, she had an outpatient spine procedure by Beaumont physicians. Because she did not know if she received the minimally invasive trial procedure or a placebo, she had to guess based upon results. "After the procedure, I went home and within 24 hours I could touch my toes," said Donlon, a running enthusiast and marathon competitor. "That's when I figured I had the study procedure. Within 48 hours, I was back to work." One year later, the research team confirmed what she suspected; she had undergone the nerve ablation treatment.

The treatment uses radio frequency energy to disable the targeted-nerve responsible for low back pain. Under local anesthesia with mild sedation, through a small opening in the patient's back, an access tube is inserted into a specific bony structure of the spine, called a vertebral body. Radio frequency energy is transmitted through the device, creating heat, which disables the nerve. The access tube is then removed. The minimally invasive, implant-free procedure takes less than one hour.

"This is a new way to treat back pain. This type of treatment has never been done before," said Dr. Fischgrund. "It's revolutionary, compared to more traditional therapies; the odds of success are much greater."

Patients eligible for this new procedure typically are candidates for more invasive back surgery or take strong pain medications, like opioids. Those research participants that had the radio frequency ablation procedure noticed significant improvement in their back pain within two weeks of surgery.

The nerve ablation procedure and technology was developed by Relievant Medsystems Inc., a California-based medical device company.

Nineteen months after Donlon's minimally invasive nerve ablation treatment, she said, "Today, I have no back issues. I'm pain free. In fact, since my procedure, the pain has not recurred. I'm extremely grateful for the care and treatment I've received through my participation in the lower back pain study."

For more information about this procedure, visit http://www.beaumont.org/health-wellness/news/new-back-pain-treatment-receives-fda-approval

SOURCE Beaumont Hospital, Royal Oak

New Study Published on the "Effect of Oral Re-Esterified Omega-3 Nutritional Supplementation on Dry Eyes"

Newly published study available online, ahead of print, in Cornea demonstrates oral consumption of re-esterified omega-3 fatty acids is an effective treatment of dry eye disease and results in a statistically significant improvement in its primary endpoint of tear osmolarity, as well as, its secondary endpoints after 12-weeks. The full study can be viewed on the Cornea website here.

One hundred and five subjects completed the study, "Eff­ect of Oral Re-Esterified Omega-3 Nutritional Supplementation on Dry-Eyes," which assessed oral nutrition as the primary therapy for dry eye disease in patients with confirmed, Meibomian gland dysfunction and specifically focused on the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, MMP-9, Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), Schirmer's score, corneal staining, and Omega Index.

This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. The study subjects (54 in treatment group, 51 in control group) were randomized to receive 4 softgels (PRN Dry Eye Omega Benefits^®, Physician Recommended Nutriceuticals, Plymouth Meeting, PA) containing a total of 1680 mg of eicosapentaenoic acid (EPA)/560 mg of docosahexaenoic acid (DHA) or a control of 3136 mg of safflower oil (linoleic acid (LA)), daily for 12 weeks. Study participants were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks. 

Alice T. Epitropoulos, MD, FACS, who served as lead investigator on the study stated, "The findings here are game changing. The research shows that omega-3s administered in the proper dose and in a cleaned triglyceride form can not only provide the necessary lipids for the tear film to impact tear osmolarity and tear break-up time, the data also demonstrates that re-esterified triglyceride omega-3 fatty acid supplementation is a vital option for patients with Meibomian Gland Disease and should be considered by all ophthalmologists treating dry eye patients. Dr. Epitropoulos also stated, "With PRN Dry Eye Omega Benefits^®, we have finally found another effective primary therapy for MGD. Omega-3s in this dose and form should be utilized to correct an unstable tear film and reduce inflammatory mediators that should have a significant impact on reducing patient discomfort. The findings of this study have the potential to impact many of the 25 million Americans suffering from dry eye symptoms."

Dr. Epitropoulos acknowledges the 11 investigators that were integral in completing this study. The investigators include Eric D. Donnenfeld, MD, Zubin A. Shah, MPH, Edward J. Holland, MD, Michael Gross, MD, William J. Faulkner, MD, Cynthia Matossian, MD, Stephen S. Lane, MD, Melissa Toyos, MD, Frank A. Bucci, MD, Henry D. Perry, MD.

About Alice T. Epitropoulos, MD, FACS

Alice T. Epitropoulos is a board certified ophthalmologist who specializes in refractive and cataract surgery and has a Dry Eye Center of Excellence. She offers femtosecond laser cataract surgery with premium lens surgery for her cataract patients. Currently, Dr. Epitropoulos has a patent of a medical device known as the EpiGlare Tester to measure visual disability from oncoming headlights in cataract patients. There was a multicenter clinical trial to validate the device, and recently signed a license agreement to manufacture, market and distribute the device with Eye Care and Cure. She is a native of Columbus, Ohio. She is a founding member and proud to be a part of The Eye Center of Columbus, an innovative affiliation of more than 80 ophthalmologists located in Downtown Columbus. Dr. Epitropoulos also serves as a clinical assistant professor in the Department of Ophthalmology at The Ohio State University. Epitropoulos received her bachelor's degree in Nursing and her medical degree both from The Ohio State University. Several of her articles have been published in prominent ophthalmic journals, and she has presented numerous papers at respected national eye meetings. Dr. Epitropoulos also serves as one of the team physicians for the Columbus Blue Jackets.

The Cataract and Refractive Center of Ohio is a subsidiary of Ophthalmic Surgeons & Consultants of Ohio Inc.

SOURCE PRN Physician Recommended Nutriceuticals

From the Alzheimer's Association International Conference 2016: A 6-Year Trial with a Vascular Care Intervention to Prevent Dementia

Important clinical trial results in Alzheimer's disease and dementia are being reported at the 2016 Alzheimer's Association International Conference (AAIC 2016) in Toronto, Canada.

Scientists from the Netherlands found that a six-year, nurse-led vascular care intervention did not lead to a reduction of all-cause dementia in a cognitively healthy population. However, fewer cases of non-Alzheimer's dementia were observed in the intervention group compared to the control group. In addition, they saw fewer cases of incident dementia in a subgroup of people in the study with untreated hypertension who were adherent to the intervention.

"The preDIVA Study was negative on the primary outcomes. However, the other study observations suggest once again the benefits—for the head and the heart—of assessing, treating, and managing heart health risk factors as we age," said Maria C. Carrillo, PhD, chief science officer, Alzheimer's Association.

Alzheimer's is the most common form of dementia, a general term for memory loss and other intellectual abilities serious enough to interfere with daily life. Alzheimer's disease accounts for 60 to 80 percent of dementia cases. According to Alzheimer's Association's 2016 Alzheimer's Disease Facts and Figures, of the 5.4 million Americans with Alzheimer's, an estimated 5.2 million people are age 65 and older, and approximately 200,000 individuals are under age 65 (younger-onset Alzheimer's).

According to the World Alzheimer Report 2015 from Alzheimer's Disease International, an estimated 46.8 million people worldwide are living with dementia in 2015. This number will almost double every 20 years, reaching 74.7 million in 2030 and 131.5 million in 2050.

Six-Year Vascular Care Intervention May Reduce New Cases of Dementia

Heart health and lifestyle-related risk factors are associated with risk of cognitive decline and dementia, but it is not fully known whether targeting these risk factors prevents dementia. In an article published in May 2015 in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, Baumgart et al wrote "there is sufficiently strong evidence, from a population-based perspective, to conclude that regular physical activity and management of cardiovascular risk factors (diabetes, obesity, smoking, and hypertension) reduce the risk of cognitive decline and may reduce the risk of dementia."

In the Prevention of Dementia By Intensive Vascular Care (preDIVA) trial, researchers in the Netherlands co-led by Dr. Edo Richard tested whether a multicomponent intervention targeting vascular risk factors can prevent new cases of dementia. Richard is a neurologist in the department of neurology at the Academic Medical Center in Amsterdam and the Radboud University medical center in Nijmegen.

The researchers conducted a six-year, open cluster-randomized controlled clinical trial in primary care where 3,526 cognitively healthy persons age 70-78 were randomized to either usual care (1,636 participants) or usual care plus three additional visits per year led by a nurse and focused on vascular care (1,890 participants). Primary outcomes were cumulative dementia incidence and disability. Main secondary outcomes were incident cardiovascular disease, mortality, and dementia by subtype.

Vascular risk factors were assessed and addressed with medical and non-medical strategies in all study participants based on primary care guidelines in the Netherlands. The study intervention under investigation involved meeting with a nurse every four months to monitor and encourage compliance and to optimize treatment of vascular risk factors. Attending at least two-thirds of appointments with the nurse over the course of the study was considered adherence to the intervention.

In results reported at AAIC 2016, after a median follow-up of 6.7 years:

• New cases of all-cause dementia and of Alzheimer's disease specifically did not significantly differ between groups.
• Dementia other than Alzheimer's occurred significantly less frequently in the intervention group (11 (1%) of 1,743) than in the control group (23 (2%) of 1,512) (HR 0.37; p=0.007).
• In a per-protocol analysis, in a subgroup of study participants with untreated hypertension who were adherent to the intervention, new dementia cases were significantly fewer in the intervention group (22 (4%) of 512) compared with the control group (35 (7%) of 471) (HR 0.54; p=0.02).

"Though we were not able to show an effect on the primary outcome, our study shows that long-term, nurse-led vascular care in an unselected population of community dwelling older people is safe and may reduce incidence of non-Alzheimer's dementia," said Richard. "In addition, we saw potentially clinically meaningful effects in lowering incident dementia in people with untreated hypertension who were adherent to the intervention."

Complete data for the primary outcome were obtained for 3,454 persons (98%). Dementia occurred in 233 participants (6.7%; 121 intervention, 112 control); 578 participants (16.4%) died. Mean blood pressure decreased significantly in both groups, but more in the intervention group than in the control group (Δ2.1 mmHG, p<0.001).

According to the researchers, preDIVA is the largest and longest-running randomized clinical trial with incident dementia as primary outcome.

About AAIC

The Alzheimer's Association International Conference (AAIC) is the world's largest gathering of researchers from around the world focused on Alzheimer's and other dementias. As a part of the Alzheimer's Association's research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community.
AAIC 2016 home page: www.alz.org/aaic/ 
AAIC 2016 newsroom: www.alz.org/aaic/press.asp

• Edo Richard, MD, PhD, et al. Prevention of Dementia By Intensive Vascular Care (preDIVA) – a Cluster-Randomized Trial. (Funders: Dutch Ministry of Health, Welfare and Sport; Dutch Innovation Fund of Collaborative Health Insurances; Netherlands Organization for Health Research and Development)

SOURCE Alzheimer's Association