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Physical Activity for Alzheimer's Disease (PAAD-2 Trial)
N/A
Waitlist Available
Led By Jennifer Etnier, PhD
Research Sponsored by University of North Carolina, Greensboro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pretest, 6 months, and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess the effects of exercise on middle-aged adults who have a heightened risk of Alzheimer's disease due to family history. The investigators will also assess the extent to which this effect is moderated by apolipoprotein epsilon-4 (APOE4) carrier status.
Who is the study for?
This trial is for middle-aged adults (40-65 years) with a family history of Alzheimer's who are not currently active, can communicate in English, and are willing to participate in all study activities for a year. It excludes those with cognitive impairment, severe medical conditions, long travel plans during the study, or on certain medications.
What is being tested?
The PAAD-2 trial examines how exercise affects cognition in people at high risk of Alzheimer's due to family history and APOE4 gene status. Participants will be randomly assigned to an exercise regimen and monitored for changes in cognitive performance.
What are the potential side effects?
Since this trial involves physical activity as an intervention, potential side effects may include typical exercise-related issues such as muscle soreness or strain but should generally be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pretest, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pretest, 6 months, and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in performance on the cognitive domain of attention as measured with the Forward Digit Span test
Change in performance on the cognitive domain of attention as measured with the Paced Auditory Serial Addition Test
Change in performance on the cognitive domain of executive function as measured with Dimensional Change Card Sort
+15 moreSecondary study objectives
Change in blood biomarkers (BDNF, irisin, IGF-1, glucose, insulin, TNF-⍺, serum amyloid protein (SAP), albumin, ApoE and ⍺-2 macroglobulin)
Change in brain activity (resting-state connectivity)
Change in brain morphology (whole brain and hippocampal volumes)
+1 moreAwards & 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: Physical Activity Condition (PAC)Experimental Treatment1 Intervention
Subjects will be asked to attend virtual exercise sessions 3 times a week for 1 year.
Group II: Usual Care Control (UCC)Active Control1 Intervention
Participants in the usual care control will maintain their normal health practices for 1 year. Participants will receive a bi-weekly health newsletter and will be contacted bi-weekly to answer any questions and inquire about the participant's health. Participants self-reported physical activity will be assessed monthly. In this fashion, participants will be contacted by staff every week. Usual care control participants that complete all study related activities including pre-, mid-, and post-test will receive a short-term YMCA membership after post-test.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesOTHER
1,392 Previous Clinical Trials
2,451,666 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,783 Previous Clinical Trials
28,183,983 Total Patients Enrolled
University of North Carolina, GreensboroLead Sponsor
32 Previous Clinical Trials
16,481 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your family has a history of Alzheimer's disease or memory problems.You have noticeable problems with memory or thinking.You have a history of serious neurologic or psychiatric conditions that could make it unsafe for you to participate in the study.You are not able to do physical activities because of heart, metabolism, or kidney problems, or because of bone and joint issues.You are currently taking medication for Alzheimer's disease or for heart rate that may affect your thinking ability.You have symptoms of depression based on a short questionnaire.Your family has a history of Alzheimer's disease or memory problems.You are not currently exercising at least 30 minutes, 3 days a week for the past 3 months.You can speak and understand English.You are okay with being randomly assigned to one of two groups in the study.You are willing to complete all study activities for 1 year.You are not currently exercising at least 3 days a week for 30 minutes each time, and you have not been doing this for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Control (UCC)
- Group 2: Physical Activity Condition (PAC)
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.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT03876314 — N/A
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