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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03746366
Enrollment
39
Registered
2018-11-19
Start date
2018-12-01
Completion date
2020-07-01
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

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.

Interventions

RADIATION[C-11]

Radiolabel

DRUGPittsburgh Compound B

Tracer

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

\[C-11\]PiB

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
[C-11]PIB +Baselinepositive/negative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026