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ALTO-100 · 4 trials · 3 indications
MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
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 score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.
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 score change from Screening (Day \[-21\]) to the end of treatment (Day 56) is the primary outcome.
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.
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
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.
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.
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.
Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
| Arm | Type | Description |
|---|---|---|
| ALTO-100 | EXPERIMENTAL | Participants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks). |
| Placebo DB | PLACEBO_COMPARATOR | Participants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. |
| Name | Type | Description |
|---|---|---|
| ALTO-100 | DRUG | ALTO-100 40 mg tablet BID |
| Placebo | DRUG | Placebo tablet BID |
| ALTO-100 PO Tablet | DRUG | Two tablets daily |
Inclusion Criteria: * Have a diagnosis of BD-I or BD-II as well as BD-D * At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and/or taking an approved atypical antipsychotic medication (olanzapine, quetiap...
ALTO-100 is an investigational small molecule being studied for the treatment of Major Depressive Disorder (MDD) and Bipolar Disorder I or II with a major depressive episode. It is also being evaluated in patients with post-traumatic stress disorder in earlier clinical work. The drug is currently in Phase 2 clinical development.
ALTO-100 is being developed by Alto Neuroscience, Inc., a biopharmaceutical company focused on psychiatry. The company's stock trades under the ticker symbol ANRO. Alto Neuroscience is conducting clinical trials of ALTO-100 in the United States.
ALTO-100 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The most advanced study is a Phase 2b trial in Major Depressive Disorder, which has been completed, and a Phase 2 trial in bipolar depression is currently recruiting participants.
ALTO-100 has been studied in several clinical trials. Completed Phase 2 trials include NCT05117632 in MDD and PTSD, NCT05419869 a pilot decentralized trial in MDD, and NCT05712187 a Phase 2b study in MDD. An ongoing Phase 2 trial, NCT06656416, is recruiting patients with Bipolar Disorder I or II with a major depressive episode.
Yes, ALTO-100 is being studied in bipolar disorder. A Phase 2 clinical trial, NCT06656416, is currently recruiting participants with Bipolar Disorder I or II who are experiencing a major depressive episode. The trial is being conducted in the United States and aims to enroll approximately 200 participants.
Across its clinical development program, ALTO-100 has been studied in trials with a total planned or actual enrollment of about 567 participants. The largest completed trial enrolled 301 people with Major Depressive Disorder, and the ongoing bipolar depression trial is designed to enroll 200 participants.