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Lifestyle Intervention with Coaching for Cognitive Impairment (PREVENTION Trial)

N/A
Recruiting
Research Sponsored by John Wayne Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with FAST Stage 4 must have a caregiver or legally appointed representative willing to accompany participants to the required procedures.
Subjects must be age 50 to 80 at time of informed consent.
Must not have
Subjects with an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Dementia, Frontal-Temporal Dementia).
Subjects with a diagnosis of cerebrovascular disease as the primary cause of cognitive impairment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is a 12-month, two-arm randomized clinical trial (RCT) in adults 50-80 years old experiencing cognitive decline. The objective is to evaluate the efficacy of a coached, data-driven, multi-modal lifestyle intervention to treat cognitive decline.

Who is the study for?
Adults aged 50-80 with mild Alzheimer's Disease, mild cognitive impairment, or subjective memory complaints are eligible. They must be proficient in English, stable on medications for chronic conditions, able to use a computer and the Internet, and willing to undergo an amyloid PET scan showing evidence of AD pathology.
What is being tested?
The trial tests two approaches over 12 months: one group receives data-driven clinical recommendations (Active Control), while the other gets these plus a coached multi-modal lifestyle intervention including health coaching sessions, dietary counseling, exercise classes (CogFit), and at-home neurocognitive programs.
What are the potential side effects?
Since this is a non-drug intervention focusing on lifestyle changes and cognitive exercises, typical drug side effects are not expected. However, participants may experience fatigue or discomfort from new physical activities or diet changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a caregiver or legal representative to accompany me for my treatments.
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I am between 50 and 80 years old.
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My functional status is moderately affected by my condition.
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I am willing to have an amyloid PET scan or share my positive amyloid PET scan results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a neurodegenerative disorder that is not Alzheimer's.
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My cognitive issues are mainly due to a cerebrovascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hippocampal Volume
NIH ToolBox Cognition Function Battery - Cognitive Function Composite Score
RAVLT (Rey's Auditory Verbal Learning Test) score
Secondary study objectives
Blood Urine Nitrogen

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 - Data-driven coached multi-modal intervention (MMIC)Experimental Treatment1 Intervention
Data-driven coached multi-modal intervention (MMIC)
Group II: Group 1 - Data-driven clinical recommendations (CR)Active Control1 Intervention
Data-driven clinical recommendations (CR)

Find a Location

Who is running the clinical trial?

John Wayne Cancer InstituteLead Sponsor
21 Previous Clinical Trials
5,489 Total Patients Enrolled
Saint John's Cancer InstituteLead Sponsor
25 Previous Clinical Trials
6,735 Total Patients Enrolled
Institute for Systems BiologyUNKNOWN
3 Previous Clinical Trials
268 Total Patients Enrolled

Media Library

Coached Data-Driven Clinical Recommendations Clinical Trial Eligibility Overview. Trial Name: NCT04082611 — N/A
Alzheimer's Disease Research Study Groups: Group 1 - Data-driven clinical recommendations (CR), Group 2 - Data-driven coached multi-modal intervention (MMIC)
Alzheimer's Disease Clinical Trial 2023: Coached Data-Driven Clinical Recommendations Highlights & Side Effects. Trial Name: NCT04082611 — N/A
Coached Data-Driven Clinical Recommendations 2023 Treatment Timeline for Medical Study. Trial Name: NCT04082611 — N/A
~1 spots leftby Jan 2025
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