[C-11]PiB PET Imaging in Alcohol Use Disorders

July 1, 2020 updated by: Rajesh Narendran, University of Pittsburgh

Imaging Beta-amyloid in Middle Age Alcoholics as a Mechanism That Increases Their Risk for Alzheimer's Disease

To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+) compared to an age-matched cognitively normal control group (HC).

Study Overview

Status

Completed

Detailed Description

There is a long-established relationship between alcohol use disorders (AUD), cognitive impairments, and the development of dementia. Some, but not all basic data suggest that alcohol abuse can alter the expression of amyloid precursor protein, and the enzymes that process it. Thus, there is a need for in vivo PET studies to further investigate the relationship between AUD and AD and the mechanism through which alcohol abuse exerts its effect on this type of dementia. Here, we propose to use the amyloid Beta (ABeta) radiotracer carbon-11 labeled Pittsburgh Compound-B ([C-11]PiB) and PET (Klunk et al., 2004) to determine whether AUD increase the risk to be brain ABeta+ in middle aged adults.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Early Phase 1

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

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsbyurgh PET Facility

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

[A] Alcohol Use Disorder Subjects (AUD)

Inclusion Criteria:

  1. Males or females between 40 and 65 years old
  2. Fulfill DSM-5 criteria for alcohol use disorder of at least moderate severity
  3. Current heavy drinking as defined in SAMHSA criteria (i.e., drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days)

Exclusion Criteria:

  1. DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder (SCID-5) and prior history of developmental disorders, such as Autism, Down's Syndrome, Intellectual disability.
  2. A positive urine drug screen at screening for amphetamines, cocaine, methamphetamine, opioids, barbituates and PCP
  3. History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
  4. History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
  5. Currently pregnant or breastfeeding
  6. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
  7. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
  8. No first-degree relative with Alzheimer's disease or related dementias

(B) Healthy Control Subjects (HC)

Inclusion Criteria:

(1) Males or females between 40 and 65 years old

Exclusion criteria:

  1. Current or past DSM-5 psychiatric and/or addictive disorders
  2. Current heavy drinking as defined in SAMHSA criteria
  3. History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
  4. History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
  5. Currently pregnant or breastfeeding
  6. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
  7. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
  8. No first-degree relative with Alzheimer's disease or related dementias

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

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol use disorders
[C-11]Pittsburgh Compound B (PiB) PET scan
Radiolabel
Tracer
Experimental: Healthy controls
[C-11]Pittsburgh Compound B (PiB) PET scan
Radiolabel
Tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[C-11]PIB +
Time Frame: Baseline
positive/negative
Baseline

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 1, 2018

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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