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

University of Pittsburgh

Status and phase: Completed; Early Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: Pittsburgh Compound B; Radiation: [C-11]

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03746366

R01AA025247 (U.S. NIH Grant/Contract)

PRO18080481

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

[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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Alcohol use disorders

Experimental group

Description:

\[C-11\]Pittsburgh Compound B (PiB) PET scan

Treatment:

Radiation: [C-11]

Drug: Pittsburgh Compound B

Healthy controls

Experimental group

Description:

\[C-11\]Pittsburgh Compound B (PiB) PET scan

Treatment:

Radiation: [C-11]

Drug: Pittsburgh Compound B