SV2A in Older Adults | NCT05465538

Studies
SV2A in Older Adults

NCT05465538

Sponsor

Yale University

Status

Recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

24Estimated

Phase

Phase 1Phase 2

Conditions

Cannabis Use

Interventions

[11C]UCB-J PET

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2022Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Jul 16, 2022

First Submission Date that Met QC Criteria

Jul 16, 2022

First Posted Date

Jul 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2026

Last Update Posted Date

Feb 27, 2026Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cannabis using older adults	Other	Subjects undergo a single PET scan using [11C]UCB-J	Drug: [11C]UCB-J PET
Healthy controls	Other	Subjects undergo a single PET scan using [11C]UCB-J	Drug: [11C]UCB-J PET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[11C]UCB-J PET	Drug	Single PET scan using the radioligand [11C]UCB-J	Cannabis using older adults Healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hippocampal synaptic density	Measure of synaptic density in the hippocampus	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Angerlyk Frytz, MD	Contact	203-974-7822		angerlyk.frytz@yale.edu

Overall Officials

Name	Affiliation	Role
Deepak C D'Souza, MBBS, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Conneticut Mental Health Center	Recruiting	New Haven	Connecticut	06519	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided