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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03089827
• Other study ID #: IRB00027675
• Status: Enrolling by invitation
• Start date: May 21, 2014
• Est. completion date: April 2031

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: April 2031
• Est. primary completion date: April 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amyloid deposition	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