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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

PREVENTION Trial 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.Check my eligibility

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.See study design

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.

PREVENTION Trial 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.

PREVENTION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hippocampal Volume

NIH ToolBox Cognition Function Battery - Cognitive Function Composite Score

RAVLT (Rey's Auditory Verbal Learning Test) score

Secondary outcome measures

Blood Urine Nitrogen

PREVENTION 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)

0 / 4Eligibility criteria met

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

6,967 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for individuals to join this medical experiment?

"Accurate. According to the data on clinicaltrials.gov, this research study began recruiting participants on July 12th 2019 and is still actively searching for candidates as of June 11th 2022. Sixty people need to be recruited from a single location."

Answered by AI

How many individuals can partake in this clinical experiment?

"Correct. Clinicaltrials.gov documents show that this experiment, first uploaded on July 12th 2019, is actively seeking volunteers. Approximately 60 individuals are desired from a single facility for the trial's duration."

Answered by AI

Who has the aptitude to partake in this scientific experiment?

"This research is looking to recruit 60 Alzheimer's disease patients between the ages of 50-80 that meet a specific set of criteria. These include: neurological and physical evaluations confirming no abnormal signs, an MMSE score greater than 19, stability on current medications for three months prior, ability to communicate with coaches telephonically or through video calls, having a caregiver/representative for those in FAST Stage 4, eligible regardless of gender/race/ethnicity have a FAST stage from 2-4 and be able to access computers and web interfaces either independently or with available help."

Answered by AI