Alzheimer DiseaseNCT03089827
Biodistribution of [11C]PIB in Patients With Risk Factors for Alzheimer's Disease
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2014to Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults enrolled with the Alzheimer's Disease Research Center at Wake Forest School of Medicine will be invited to participate,
Who may be able to join
- Enrolled in a study with the Alzheimer's Disease Research Center.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Memory
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start21 May 2014
- Primary completionApr 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Craft, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089827
- Sponsor's protocol ID
- IRB00027675
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2017
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution of [11C]PIB in Patients With Risk Factors for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03089827
- Acronym / sponsor ID
- IRB00027675
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Memory
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 21 May 2014 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults enrolled with the Alzheimer's Disease Research Center at Wake Forest School of Medicine will be invited to participate,
Key inclusion criteria (1 listed)
- Enrolled in a study with the Alzheimer's Disease Research Center.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Craft, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloid deposition (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.