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Physical Activity for Alzheimer's Disease (PAAD-2 Trial)

N/A

Recruiting

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

PAAD-2 Trial 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.

Eligible Conditions

Alzheimer's Disease
Dementia
Healthy Subjects
Physical Activity

PAAD-2 Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and pretest, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

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 more

Secondary outcome measures

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 more

PAAD-2 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesOTHER

1,240 Previous Clinical Trials

1,003,967 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,004,874 Total Patients Enrolled

University of North Carolina, GreensboroLead Sponsor

31 Previous Clinical Trials

16,401 Total Patients Enrolled

Media Library

Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT03876314 — N/A

Alzheimer's Disease Research Study Groups: Usual Care Control (UCC), Physical Activity Condition (PAC)

Alzheimer's Disease Clinical Trial 2023: Physical Activity Highlights & Side Effects. Trial Name: NCT03876314 — N/A

Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT03876314 — N/A

Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT03876314 — N/A

Frequently Asked Questions

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

For what demographic is this research endeavor appropriate?

"The study is actively seeking 240 participants between the ages of 40 and 65 with a family history of Alzheimer's disease, cognitive deficits, an insufficient amount of physical activity (less than 3 months), who are willing to be randomized into either condition and complete all activities for one year. Fluency in English is also necessary."

Answered by AI

What primary goals are this research project attempting to accomplish?

"The primary purpose of this trial, which will be measured at Pre-test, 6 months and 12 months is to observe the evolution in cognitive executive function as captured by Matrix Reasoning. Secondary objectives involve tracking changes in brain morphology (whole brain and hippocampal volumes) via MRI scans; examining alterations in resting-state connectivity with fMRI readings; and exploring variations in blood biomarkers such as BDNF, irisin, IGF-1, glucose, insulin TNF-⍺ SAP albumin ApoE ⍺2 macroglobulin determined from a post fasting sample."

Answered by AI

What is the current count of trial participants in this investigation?

"Affirmative. Per the information presented on clinicaltrials.gov, this trial is engaging participants at present. This research was introduced on May 23rd 2019 and has been most recently updated October 31st 2022. In total, 240 individuals are being enlisted from one site for this study."

Answered by AI

Are new participants being welcomed into this experiment?

"Current records on clinicaltrials.gov show that this ongoing trial is actively seeking participants, which was initially posted on May 23rd 2019 and recently updated October 31st 2022."

Answered by AI