The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design.
Jared C Roach, Junko Hara, Deborah Fridman...
https://pubmed.ncbi.nlm.nih.gov/35910672/Actively Recruiting
Led by HudsonAlpha Institute for Biotechnology · Updated on 2025-08-28
200
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying dementia, which has many causes and limited treatment options, focusing on individuals aged 65 to 75 who are at high risk but do not yet have cognitive impairment. The study aims to assess how people feel about their dementia risk as they receive personalized risk information and to pilot the use of data collection and a lifestyle intervention designed to reduce dementia risk factors. It also seeks to identify key risk contributors and dementia sub-types based on genetics and molecular markers. Participants are divided into two groups based on their risk for cognitive decline using factors like family history, genetics APOE genotype and Alzheimers disease polygenic risk score, cardiovascular risk, lifestyle, cognitive assessment scores, raceethnicity, and pTau217 biomarker levels. Those at high risk will be offered a multimodal lifestyle intervention that includes healthy eating MIND Diet, physical activity, stress and weight management, social and learning activities, and cognitive training through an online program. Health coaching via telephone supports participants, with coaching tailored to each individuals biological and behavioral data. During the study, researchers will track participants attitudes about dementia risk at enrollment, after they learn their risk level, and after completing the intervention if applicable. They will also measure biomarkers like pTau217 and cognitive scores MoCA at several points. The study involves surveys, cognitive assessments, physical tests, and sample collection, with participants needing internet access for some activities. This study runs from May 2025 to April 2026, with ongoing monitoring to evaluate the impact of personalized risk information and lifestyle changes on dementia risk.
CONDITIONS
Impact of a Multimodal Lifestyle Intervention on Dementia Risk Factors and Attitude Related to Dementia Risk: A Logistical Pilot Study
J
Jesse N Cochran, PhD
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HudsonAlpha Institute for Biotechnology
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Study’s intervention | External contextual comparator |
|---|---|---|
| What it is | A tailored multimodal lifestyle program delivered via telephone coaches combining MIND diet, physical activity, stress and weight management, social and learning activities, cognitive training tools and biomarker‑guided personalization. | A structured 2‑year multidomain lifestyle program including dietary guidance, physical exercise, cognitive and social stimulation, and vascular risk monitoring, as used in the FINGER trial. |
| Role in study | Applied sequentially to participants identified as high risk for conversion to cognitive impairment. | Serves as an established prevention model but was not tested in this study. |
| Primary use | Test whether a personalized, coach‑supported multimodal lifestyle intervention reduces dementia risk factors and influences attitudes. | Demonstrated potential to improve cognition among at‑risk older adults over two years. |
| How it is delivered | Delivered by telephone‑based coaching from licensed allied health providers, tailored based on each individual’s biomarker and behavioral data. | Delivered via scheduled in‑person dietary counseling, supervised exercise, cognitive training sessions, group activities, and regular vascular monitoring over two years. |
| Evidence status | Evidence for benefit is under investigation in this pilot study; results not yet established. | Improved cognitive performance domains compared with control over two years in a randomized trial. |
| Important limitations | Single‑group design without internal control limits causal inference and relies on external comparison for context. | Trial context differs—FINGER was randomized over two years, whereas this pilot uses telephone coaching and may not replicate exact settings or durations. |
| Patient impact | Not yet known; this study aims to examine changes in dementia risk attitudes and biomarkers. | Demonstrated moderate cognitive improvement across domains after two years compared with control. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants at high risk for cognitive impairment receive a multimodal lifestyle intervention including healthy nutrition, physical activity, stress management, weight management, cognitive training, and telephone-based health coaching tailored to their individual health data.
Regular coaching and assessments throughout the intervention period
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor