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

Early Phase 1

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Radiation: [C-11]; Drug: Pittsburgh Compound B

• Registration Number: NCT03746366
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2018-12-01
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol use disorders	[C-11]	\[C-11\]Pittsburgh Compound B (PiB) PET scan
Healthy controls	[C-11]	\[C-11\]Pittsburgh Compound B (PiB) PET scan
Alcohol use disorders	Pittsburgh Compound B	\[C-11\]Pittsburgh Compound B (PiB) PET scan
Healthy controls	Pittsburgh Compound B	\[C-11\]Pittsburgh Compound B (PiB) PET scan

Primary Outcome Measures

Name	Time	Method
[C-11]PIB +	Baseline	positive/negative

Trial Locations

Locations (1)

University of Pittsbyurgh PET Facility; 🇺🇸 Pittsburgh, Pennsylvania, United States