CClinicalTrials.gg
RecruitingNCT05465538Updated Feb 27, 2026

SV2A in Older Adults

A Phase 1/2 interventional study of [11C]UCB-J PET in Cannabis Use, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Yale University · Phase 1/2, Interventional, and Other

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 3 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cannabis Use
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Other
    Cannabis using older adults

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

    Drug: [11C]UCB-J PET

  • Other
    Healthy controls

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

    Drug: [11C]UCB-J PET

Interventions

  • Drug[11C]UCB-J PET

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

06

What researchers measure

Primary outcomes

  1. Hippocampal synaptic density

    Measure of synaptic density in the hippocampus

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Conneticut Mental Health Center
    New Haven, Connecticut 06519, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05465538
Lead sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Deepak C. D'Souza (Principal Investigator, Yale University) — Principal investigator
First posted
Jul 19, 2022
Start date
Jul 6, 2022
Primary completion
Dec 30, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

Angerlyk Frytz, MD
Contact
angerlyk.frytz@yale.edu
203-974-7822
Deepak C D'Souza, MBBS, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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