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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746366
• Other study ID #: PRO18080481
• Secondary ID: R01AA025247
• Status: Completed
• Phase: Early Phase 1
• Start date: December 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

[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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Radiation:
• [C-11]
Radiolabel

Drug:
• Pittsburgh Compound B
Tracer

Locations

Country	Name	City	State
United States	University of Pittsbyurgh PET Facility	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[C-11]PIB +	positive/negative	Baseline