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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 belowSelect...
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:Select...
I have been diagnosed with a neurodegenerative disorder that is not Alzheimer's.
Select...
My cognitive issues are mainly due to a cerebrovascular disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
St. Joseph's Healthcare FoundationOTHER
5 Previous Clinical Trials
315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My gender, race, or ethnicity does not limit my participation.I have a caregiver or legal representative to accompany me for my treatments.I can use a mobile phone, iPad, or computer as confirmed by staff.You have a high score on a test for dementia.My health conditions are stable, and I haven't started new meds for them in the last 3 months.I am between 50 and 80 years old.I or my immediate family have a high-risk gene mutation for Alzheimer's.My doctor says I can do moderate exercise.You should have normal eyesight or corrected eyesight and normal color vision based on your own report.My functional status is moderately affected by my condition.I have been diagnosed with a neurodegenerative disorder that is not Alzheimer's.I am willing to have an amyloid PET scan or share my positive amyloid PET scan results.If you score below 20 on a test called the Mini Mental State Exam (MMSE), you may not be able to join the study.My cognitive issues are mainly due to a cerebrovascular disease.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 - Data-driven clinical recommendations (CR)
- Group 2: Group 2 - Data-driven coached multi-modal intervention (MMIC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.