SV2A in Older Adults

Yale University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cannabis Use

Treatments: Drug: [11C]UCB-J PET

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05465538

2000032183

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Cannabis using older adults

Other group

Description:

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

Treatment:

Drug: [11C]UCB-J PET

Healthy controls

Other group

Description:

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

Treatment:

Drug: [11C]UCB-J PET