Biodistribution of [11C]PIB in Patients With Risk Factors for Alzheimer's Disease

February 29, 2024 updated by: Wake Forest University Health Sciences
Participants enrolled at the Alzheimer's Disease Research Center (ADRC) at Wake Forest School of Medicine will be invited to take part in this study. The purpose of this study is to identify and measure the amount of a protein called amyloid in the brain.It is thought that the build up of amyloid may be related to the development of Alzheimer's disease.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Brain amyloid will be measured using PET with [11C]PiB. Participation will involve an initial brain scan and possibly a follow-up brain scan two years later.

The data collected in this study will help explain amyloid deposits in several groups of participants including adults with and without signs of memory impairment. The information collected will help find out who is more likely to have brain amyloid and when it increases the risk for developing memory problems. Research studies suggest that people with elevated levels of brain amyloid are at an increased risk for memory decline, but this does not mean that every person with amyloid build up will develop AD.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adults enrolled with the Alzheimer's Disease Research Center at Wake Forest School of Medicine will be invited to participate,

Description

Inclusion Criteria:

  • Enrolled in a study with the Alzheimer's Disease Research Center.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amyloid deposition
Time Frame: 2 years
Studying the initial amyloid deposition in participants as well as their rate of amyloid accumulation over time will help establish whether there is an early therapeutic window for intervention in high risk patients.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Suzanne Craft, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2014

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 17, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00027675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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