Study Results
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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RECRUITING
PHASE2
82 participants
INTERVENTIONAL
2024-06-11
2026-03-31
Brief Summary
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Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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ALTO-101
10 days administration of ALTO-101T transdermal delivery system
ALTO-101
ALTO-101 patches
ALTO-101 Transdermal Delivery System
ALTO-101 transdermal delivery system
Placebo
10 days administration of placebo transdermal delivery system
Placebo
Inactive placebo patches
Placebo Transdermal Delivery System
Placebo transdermal delivery system
Interventions
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ALTO-101
ALTO-101 patches
ALTO-101 Transdermal Delivery System
ALTO-101 transdermal delivery system
Placebo
Inactive placebo patches
Placebo Transdermal Delivery System
Placebo transdermal delivery system
Eligibility Criteria
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Inclusion Criteria
* Cognitive impairment
* Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
* Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
* Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
* Willing to comply with all study assessments and procedures
Exclusion Criteria
* Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
* Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
* Current episode of major depressive disorder (MDD)
* Use of mood stabilizer, clozapine, and/or daily benzodiazepine
* Current moderate or severe substance use disorder
21 Years
55 Years
ALL
No
Sponsors
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Alto Neuroscience
INDUSTRY
Responsible Party
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Locations
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Site 5038
Garden Grove, California, United States
Site 5063
Los Angeles, California, United States
Site 5106
Orange, California, United States
Site 5035
Walnut Creek, California, United States
Site 5060
Hollywood, Florida, United States
Site 5015
Tampa, Florida, United States
Site 5064
Snellville, Georgia, United States
Site 5056
Chicago, Illinois, United States
Site 5062
Gaithersburg, Maryland, United States
Site 5124
Belmont, Massachusetts, United States
Site 5108
New York, New York, United States
Site 5077
New York, New York, United States
Site 5109
New York, New York, United States
Site 5126
White Plains, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Clinical Operations Manager
Role: primary
Other Identifiers
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ALTO-101-201
Identifier Type: -
Identifier Source: org_study_id