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

NCT ID: NCT03746366

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

\[C-11\]PiB
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alcohol use disorders

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

Group Type EXPERIMENTAL

[C-11]

Intervention Type RADIATION

Radiolabel

Pittsburgh Compound B

Intervention Type DRUG

Tracer

Healthy controls

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

Group Type EXPERIMENTAL

[C-11]

Intervention Type RADIATION

Radiolabel

Pittsburgh Compound B

Intervention Type DRUG

Tracer

Interventions

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[C-11]

Radiolabel

Intervention Type RADIATION

Pittsburgh Compound B

Tracer

Intervention Type DRUG

Eligibility Criteria

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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)


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

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)


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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Rajesh Narendran

Professor of Radiology and Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsbyurgh PET Facility

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Flanigan MR, Royse SK, Cenkner DP, Kozinski KM, Stoughton CJ, Himes ML, Minhas DS, Lopresti B, Butters MA, Narendran R. Imaging beta-amyloid (Abeta) burden in the brains of middle-aged individuals with alcohol-use disorders: a [11C]PIB PET study. Transl Psychiatry. 2021 May 1;11(1):257. doi: 10.1038/s41398-021-01374-y.

Reference Type DERIVED
PMID: 33934110 (View on PubMed)

Other Identifiers

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R01AA025247

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO18080481

Identifier Type: -

Identifier Source: org_study_id