- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746366
[C-11]PiB PET Imaging in Alcohol Use Disorders
July 1, 2020 updated by: Rajesh Narendran, University of Pittsburgh
Imaging Beta-amyloid in Middle Age Alcoholics as a Mechanism That Increases Their Risk for Alzheimer's Disease
To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+) compared to an age-matched cognitively normal control group (HC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsbyurgh PET Facility
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
[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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alcohol use disorders
[C-11]Pittsburgh Compound B (PiB) PET scan
|
Radiolabel
Tracer
|
Experimental: Healthy controls
[C-11]Pittsburgh Compound B (PiB) PET scan
|
Radiolabel
Tracer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[C-11]PIB +
Time Frame: Baseline
|
positive/negative
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
November 16, 2018
First Submitted That Met QC Criteria
November 16, 2018
First Posted (Actual)
November 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 2, 2020
Last Update Submitted That Met QC Criteria
July 1, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO18080481
- R01AA025247 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Use Disorder
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
University of North Carolina, Chapel HillCompletedAlcohol Use Disorder, Mild | Alcohol Use Disorder, ModerateUnited States
-
Université du Québec à Trois-RivièresCompletedAlcohol Use, Unspecified | Alcohol Use Disorder, MildCanada
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Medical University of South CarolinaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institutes...RecruitingAlcohol Drinking | Substance Use | Alcohol Use Disorder | Drinking, Alcohol | Alcohol Use Disorder (AUD)United States
-
Kaiser PermanenteNORC at the University of Chicago; Agency for Healthcare Research and Quality... and other collaboratorsCompleted
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
Central Institute of Mental Health, MannheimNot yet recruitingAlcohol Use Disorder (AUD)Germany
-
Massachusetts General HospitalMbarara University of Science and TechnologyCompletedAlcohol Use Disorder (AUD)Uganda
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingNeurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use DisorderAlcohol Dependence | Alcohol-Related Disorders | Substance Use Disorders | Drug Abuse | Mental Disorder | Alcohol Abuse | Alcohol Use Disorder (AUD)
Clinical Trials on [C-11]
-
Mayo ClinicEnrolling by invitationParkinson Disease | Semantic Dementia | Behavioral Variant of Frontotemporal Dementia | CBD | Apraxia of Speech | MSA - Multiple System Atrophy | FTD | PPA | PSP | PCA | LPA | Semantic AphasiaUnited States
-
Yale UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Yale UniversityNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)Active, not recruiting
-
National Institute of Mental Health (NIMH)CompletedHealthy | AtherosclerosisUnited States
-
Brigham and Women's HospitalUnknownMultiple SclerosisUnited States
-
National Institute of Mental Health (NIMH)CompletedHealthy | NeurocysticercosisUnited States
-
National Institute of Mental Health (NIMH)CompletedHealthyUnited States
-
National Institute of Neurological Disorders and...CompletedMultiple SclerosisUnited States
-
National Cancer Institute (NCI)CompletedProstate CancerUnited States
-
National Institute of Mental Health (NIMH)Completed