SV2A in Older Adults

NCT ID: NCT05465538

Last Updated: 2025-11-05

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

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-06

Study Completion Date

2026-09-30

Brief Summary

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The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using \[11C\]UCB-J PET imaging.

Detailed Description

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Conditions

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Cannabis Use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cannabis using older adults

Subjects undergo a single PET scan using \[11C\]UCB-J

Group Type OTHER

[11C]UCB-J PET

Intervention Type DRUG

Single PET scan using the radioligand \[11C\]UCB-J

Healthy controls

Subjects undergo a single PET scan using \[11C\]UCB-J

Group Type OTHER

[11C]UCB-J PET

Intervention Type DRUG

Single PET scan using the radioligand \[11C\]UCB-J

Interventions

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[11C]UCB-J PET

Single PET scan using the radioligand \[11C\]UCB-J

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to provide informed consent
* Male or female, aged ≥50 years
* No history of significant medical or neurological disease
* BMI ≤ 50
* If woman of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans

Exclusion Criteria

* Women with a positive pregnancy test or women who are lactating
* Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits;
* History of a bleeding disorder or are currently taking anticoagulants
* Subjects who have donated blood within 8 weeks of the present study
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deepak C D'Souza, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Conneticut Mental Health Center

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angerlyk Frytz, MD

Role: CONTACT

203-974-7822

Facility Contacts

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Angerlyk Frytz, MD

Role: primary

203-974-7822

Other Identifiers

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2000032183

Identifier Type: -

Identifier Source: org_study_id

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