Back to results[C-11]PiB PET Imaging in Alcohol Use Disorders
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[C-11]
Pittsburgh Compound B
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Use Disorder
Eligibility Criteria
[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
Sites / Locations
- University of Pittsbyurgh PET Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Alcohol use disorders
Healthy controls
Arm Description
[C-11]Pittsburgh Compound B (PiB) PET scan
[C-11]Pittsburgh Compound B (PiB) PET scan
Outcomes
Primary Outcome Measures
[C-11]PIB +
positive/negative
Secondary Outcome Measures
Full Information
NCT ID
NCT03746366
First Posted
November 16, 2018
Last Updated
July 1, 2020
Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03746366
Brief Title
[C-11]PiB PET Imaging in Alcohol Use Disorders
Official Title
Imaging Beta-amyloid in Middle Age Alcoholics as a Mechanism That Increases Their Risk for Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
[C-11]PiB
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol use disorders
Arm Type
Experimental
Arm Description
[C-11]Pittsburgh Compound B (PiB) PET scan
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
[C-11]Pittsburgh Compound B (PiB) PET scan
Intervention Type
Radiation
Intervention Name(s)
[C-11]
Intervention Description
Radiolabel
Intervention Type
Drug
Intervention Name(s)
Pittsburgh Compound B
Intervention Description
Tracer
Primary Outcome Measure Information:
Title
[C-11]PIB +
Description
positive/negative
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
[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
Facility Information:
Facility Name
University of Pittsbyurgh PET Facility
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33934110
Citation
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.
Results Reference
derived
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[C-11]PiB PET Imaging in Alcohol Use Disorders
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