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Completed

NCT Number: NCT03746366

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

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pittsbyurgh PET Facility

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

[A] Alcohol Use Disorder Subjects (AUD)

Inclusion criteria

  • Males or females between 40 and 65 years old
  • Fulfill DSM-5 criteria for alcohol use disorder of at least moderate severity
  • 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

  • DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder (SCID-5) and prior history of developmental disorders, such as Autism, Down's Syndrome, Intellectual disability.
  • A positive urine drug screen at screening for amphetamines, cocaine, methamphetamine, opioids, barbituates and PCP
  • History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
  • History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
  • Currently pregnant or breastfeeding
  • Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
  • Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
  • 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

  • Current or past DSM-5 psychiatric and/or addictive disorders
  • Current heavy drinking as defined in SAMHSA criteria
  • History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
  • History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
  • Currently pregnant or breastfeeding
  • Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
  • Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
  • No first-degree relative with Alzheimer's disease or related dementias

Treatment and study plan

[C-11]

Radiation

Radiolabel

Pittsburgh Compound B

Drug

Tracer

Primary outcomes

  1. [C-11]PIB +

    Time frame: Baseline

    positive/negative

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2018
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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