Alcohol Use DisorderEarly Phase 1NCT03746366
[C-11]PiB PET Imaging in Alcohol Use Disorders
A Early Phase 1 study testing [C-11] and Pittsburgh Compound B in people with Alcohol Use Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+) compared to an age-matched cognitively normal control group (HC). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- [C-11] and Pittsburgh Compound B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Jul 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Males or females between 40 and 65 years old
Who cannot join
- 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
Show all 17Show fewer
- 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
- Healthy Control Subjects (HC)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsbyurgh PET Facility
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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).
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- [C-11], Pittsburgh Compound B
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[C-11]Radiation
Radiolabel
Pittsburgh Compound BDrug
Tracer
| Study group | Role | What they receive |
|---|---|---|
| Alcohol use disorders | Experimental | [C-11]Pittsburgh Compound B (PiB) PET scan Receives: Radiation: [C-11]; Drug: Pittsburgh Compound B |
| Healthy controls | Experimental | [C-11]Pittsburgh Compound B (PiB) PET scan Receives: Radiation: [C-11]; Drug: Pittsburgh Compound B |
What is being measured
The primary outcome is the main question the study is designed to answer.
[C-11]PIB +
positive/negative
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Dec 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- \[C-11\]PiB
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Rajesh Narendran, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746366
- Sponsor's protocol ID
- PRO18080481
- Other IDs
- R01AA025247
- Status last verified
- Jul 2020
- First submitted
- 16 Nov 2018
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33934110
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Beta-amyloid in Middle Age Alcoholics As a Mechanism That Increases Their Risk for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03746366
- Acronym / sponsor ID
- PRO18080481
- Conditions
- Alcohol Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- [C-11]PiB
| Arm | Type | Receives |
|---|---|---|
| Alcohol use disorders | Experimental | Radiation: [C-11], Drug: Pittsburgh Compound B[C-11]Pittsburgh Compound B (PiB) PET scan |
| Healthy controls | Experimental | Radiation: [C-11], Drug: Pittsburgh Compound B[C-11]Pittsburgh Compound B (PiB) PET scan |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- Males or females between 40 and 65 years old
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [C-11]Radiolabel | Radiation | Alcohol use disorders, Healthy controls |
| Pittsburgh Compound BTracer | Drug | Alcohol use disorders, Healthy controls |
Primary outcome
[C-11]PIB +
Time frame: Baseline
positive/negative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 33934110Flanigan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [C-11] and Pittsburgh Compound B in people with Alcohol Use Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[C-11]PIB + (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.