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Lifestyle Intervention for Alzheimer's Prevention (POINTER Trial)

N/A

Waitlist Available

Led By Laura D Baker, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to complete physical exercise

Be older than 18 years old

Must not have

Use of psychoactive medications for exclusionary medical conditions

Serious conduction disorder, uncontrolled arrhythmia, or specific ECG findings

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if lifestyle changes can help protect memory and thinking in older adults.

Who is the study for?

This trial is for African American/Black, Native American, or Hispanic/Latinx individuals aged 60-79 with a low MIND diet score and suboptimal cardiovascular health. It's for those who are sedentary, have a family history of memory issues but no cognitive impairment themselves. Participants must live in the study area without extended travel plans and be willing to engage in lifestyle changes for at least two years.

What is being tested?

The POINTER study tests whether lifestyle interventions like physical activity, cognitive exercises, dietary changes, and social engagement can protect against memory loss in older adults at risk. Participants will be randomly assigned to either a self-guided or structured program based on successful Finnish models.

What are the potential side effects?

Since this trial involves lifestyle modifications rather than medications, side effects are not typical as with drug trials. However, participants may experience fatigue or muscle soreness from new exercise routines or digestive changes due to diet adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to perform physical exercises.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any psychoactive drugs for certain health conditions.

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I have a serious heart rhythm problem.

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I am currently in physical therapy or cardiopulmonary rehab.

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I do not have any major neurological conditions.

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My condition meets the lung disease criteria.

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I have not had hip, joint, or spinal surgery in the last 6 months.

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I have had weight loss surgery that affects how my body absorbs food.

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I have taken medication for memory problems or Alzheimer's disease.

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I use insulin to manage my type 2 diabetes.

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I have a serious heart condition.

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I am either younger than 60 or older than 80 years old.

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My kidneys are in the final stage of failure.

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I have not had major depression in the last 6 months.

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I am currently receiving hospice care.

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I am currently taking corticosteroids every day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global cognitive function

Secondary study objectives

Clinical Dementia Rating-Sum of Boxes

Digital Clock Drawing Test (DCTClock)

Memory

+5 more

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

Group I: Structured Lifestyle InterventionExperimental Treatment1 Intervention

Lifestyle modification program that involves participants completing structured activities that target diet, physical exercise, and intellectual and social stimulation.

Group II: Self-Guided Lifestyle InterventionExperimental Treatment1 Intervention

Lifestyle modification program that is developed by the participant to meet his/her specific needs.

0 / 16Eligibility criteria met