A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT07423546
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • SCHIZOPHRENIA 1 (Disorder)
  • Schizoaffecitve Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Xanomeline and trospium chloride (KarXT) — DRUG
    Subjects will be randomized to 5 weeks of low, middle, or high dose of Xanomeline and trospium chloride, and will complete a PET scan with \[18\]F DOPA at the beginning and end of the treatment period.

Study Details

This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \[18F\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission. The overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission/synthesis capacity in the striatum and midbrain as measured by \[18F\]DOPA Kicer (\[18F\]DOPA relative uptake rate)).

Key Dates

Start date
Jul 1, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Xanomeline 50 mg and trospium chloride 20mg (KarXT)
    5 weeks of xanomeline 50mg/trospium 20mg bid (low dose arm).
  • Experimental: Xanomeline 100 mg and trospium chloride 20mg (KarXT)
    5 weeks of xanomeline 100mg/trospium 20mg bid (middle dose arm).
  • Experimental: Xanomeline 125 mg and trospium chloride 30mg (KarXT)
    5 weeks of xanomeline 125mg/trospium 30mg bid (high dose arm).

Primary Outcome Measure

[18F]DOPA Kicer ([18F]DOPA relative uptake rate) [ Time Frame: Pre/post 5 weeks of Xanomeline and trospium chloride (KarXT) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032-

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New York State Psychiatric Institute· New York, NY

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