ALTO-100 in MDD and/or PTSD

• ClinicalTrials.gov Identifier: NCT05117632
• Recruitment Status: Completed
• First Posted: November 11, 2021
• Last Update Posted: December 1, 2023
• Sponsor: Alto Neuroscience
• Information provided by (Responsible Party): Alto Neuroscience

Tracking Information

• First Submitted Date: November 2, 2021
• First Posted Date: November 11, 2021
• Last Update Posted Date: December 1, 2023
• Actual Study Start Date: December 20, 2021
• Actual Primary Completion Date: December 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2021)

• To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Measured 5 times over 8 weeks ]
  The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The change from baseline to the end of the study is the primary outcome.
• To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S) [ Time Frame: Measured 5 times over 8 weeks ]
  The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome.
• To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Measured 3 times over 8 weeks ]
  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. The change from baseline to the end of the study is the primary outcome.
• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100 [ Time Frame: From the signing of the ICF until the follow-up visit (up to 12 weeks) ]
  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
• Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100 [ Time Frame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks) ]
  Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
• Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100 [ Time Frame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks) ]
  Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ALTO-100 in MDD and/or PTSD
• Official Title: An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder
• Brief Summary: The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Major Depressive Disorder
• Post Traumatic Stress Disorder

Intervention

Drug: ALTO-100 PO tablet

one tablet twice daily

Study Arms

Experimental: ALTO-100

ALTO-100 PO tablet, daily dosing 8 weeks

Intervention: Drug: ALTO-100 PO tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 19, 2022): 245
• Original Estimated Enrollment (submitted: November 2, 2021): 350
• Actual Study Completion Date: December 9, 2022
• Actual Primary Completion Date: December 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
• At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
• Willing to comply with all study assessments and procedures
• Must not be pregnant or breastfeeding at time of enrollment or throughout study

Exclusion Criteria:

• Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease
• Active suicidal ideation
• Diagnosed bipolar disorder, psychotic disorder, or dementia
• Current moderate or severe substance use disorder
• Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
• Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05117632
• Other Study ID Numbers: ALTO-100-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alto Neuroscience
• Original Responsible Party: Same as current
• Current Study Sponsor: Alto Neuroscience
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Alto Neuroscience
• Verification Date: November 2023