UsAgainstAlzheimer’s Urges Medical System Engagement with Emerging Science Around Prevention and Early Detection, Lifestyle Changes, and Comorbidity Management to Reduce Individuals’ Risk and Rate of Cognitive Decline

Washington, D.C. (Sept. 11, 2019) – UsAgainstAlzheimer’s (UsA2) today released a new report which highlights the strengths, gaps, and opportunities for further exploration within the non-pharmacological interventions pipeline, which could slow, delay, or possibly even prevent Alzheimer’s and related dementias. Non-pharmacological treatments were defined as any replicable lifestyle intervention, such as diet and exercise or alternative approaches, such as cognitive training, medical devices, and modifiable risk factors, which may provide some quantifiable or relevant positive change in commonly reported symptoms of Alzheimer’s patients.

The report, developed by ResearchersAgainstAlzheimer’s, found that while initial research at the preclinical or early clinical stages reveals potential for non-pharmacological interventions, more expansive, multimodal studies – where two or more interventions are examined together – are needed to fully explore these preliminary results, particularly for communities of color and women. This underscores the urgent need for markedly increased funding for Alzheimer’s research at the National Institutes of Health (NIH), where 62 non-pharmacological studies are currently being conducted. The full report can be found here.

“Developing a pharmacological intervention for Alzheimer’s has proved more challenging than we could have ever expected. As we continue to pursue drug development and relentlessly accelerate towards a treatment for this disease, we must also expand our research to include non-pharmacological interventions. To date, we’re encouraged by the growing recognition of the importance of non-pharmacological interventions for Alzheimer’s at the highest levels of government, as evidenced by the recent publication of the World Health Organization’s Guidelines on Risk Reduction of Cognitive Decline and Dementia,” said George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s. “We cannot afford to leave scientific opportunity on the table. This means providing scientists and researchers, whose work is funded by the NIH, the resources they need to validate the benefits of non-pharmacological interventions with the strongest possible scientific rigor. An additional $350 million in funding for the NIH for fiscal year 2020 would allow us to keep pace with the latest science and explore both pharma and non-pharma pathways wherever they lead.”

The UsA2 report identified 55 non-pharmacological topics that researchers are investigating and assigned each a level of evidence (LOE) score, on a scale of 1 to 5, based on the number of completed preclinical and clinical studies, the number of completed meta-analyses, and the rigor of the studies’ methodology and statistics. In all, only four non-pharmacological treatments received a score of 5, including the MIND Diet; Modifiable Risk Factors, as well as the combination of Risk Factor Modification; Cognitive Training; and Aerobic Exercise. Notably, a topic’s score does not indicate the level of benefit it has, rather it is a gauge of the quantity and quality of the research completed on that topic to date. A score of three or lower is a sign that further research is needed to sufficiently evaluate its benefits.

“The latest research is showing clearly that behavior modifications can have an impact today in slowing and even possibly preventing Alzheimer’s disease,” said Dr. Mark Hyman, director of the Cleveland Clinic Center for Functional Medicine and 11-time No. 1 New York Times bestselling author. “We must dedicate more resources to studying the impact of these interventions to fully understand the potential benefits for individuals who want to do something about combatting cognitive decline.”

The report contains a series of case studies and commentary on ongoing non-pharmacological trials, which underscore breakthroughs in the space as well as opportunities for further research, including:

• FINGER Study – One of the first large multi-center Randomized Controlled Trials (RCT) to show that modifying lifestyle behaviors can drastically reduce the risk of a dementia diagnosis in elderly participants. Specifically, this multi-domain two-year RCT study found that a combination of exercise, brain games, diet, and social activity synergistically prevented the decline of cognitive function in adults with significant risk for dementia.
   
• MAD Diet – The study authors gave the MAD diet an LOE score of four in part because none of its active RCT studies had received FDA phase III designation. While findings from the completed clinical trials and published reports show that the MAD diet may have potential usefulness, active clinical trials studying it have recruitment groups of less than 150 subjects. Future research initiatives should aim to fund a large double blinded RCT that can be approved as an FDA phase III clinical trial.
   
• Aerobic Exercise – Six large RCT trials studying exercise are currently active within the United States. Two of the six have received FDA Phase III trial approval with recruitment populations over 600 study subjects. The list of completed and active clinical trials within the aerobic exercise topic are vast. However, because aerobic exercise protocols used several different types of modalities (e.g. walking, biking, cardio based exercises, etc.), future initiatives should attempt to identify which exercise modality provides the most benefit for patients.
   
• Transcranial Stimulation (tCS) – tCS has been used for many years to treat depression and several other disorders. It has also been tested for safety in many other clinical trials, benefited from decades of published literature, received FDA approval for other illnesses, and continues to receive a high level of clinical interest. And yet, such a well-studied intervention does not have a single active or upcoming FDA phase III RCT. This treatment is ripe for further study with a larger sample size.
   
• Turmeric – Turmeric (Curcumin) is known for its anti-inflammatory properties and has been studied in several other illnesses. To date, Turmeric has completed three FDA phase II studies but there are no FDA phase III trials available. According to the authors of the report, it is worth exploring the treatment in a larger multi-center double blinded RCT.
   
• BrainHQ – BrainHQ, a commercially available cognitive retraining program, has published several peer-reviewed articles using the cohort from the ACTIVE study to show significant declines in the risk of a dementia diagnosis for older adults. While BrainHQ showed slight benefits for reasoning and processing speed, closer inspection of the data underlying the program found that this was not the case for memory.

“UsAgainstAlzheimer’s new report demonstrates that we must dramatically increase the scale and scope of studies around non-pharmacological interventions, particularly with special attention to women, communities of color, and those without exposure to higher education who experience higher risk for dementia,” said David G. Morgan, Michigan State University professor of translational neuroscience. “Our focus must be on adequately funding large-scale research into lifestyle, dietary, brain training, social engagement, and medical device interventions, which are hard to support from private funding sources. It’s the only way we can give scientists the chance to conduct essential double-blinded, randomized, placebo-controlled trials, confirm findings from promising interventions, validate potential benefits, and rule out those approaches with little or no effect.”

The cost incurred by doing nothing will exact a far higher toll on our healthcare system, our economy, and the 5.8 million Americans currently living with Alzheimer’s and their 16 million caregivers.
 

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