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Also known as ALTO-100 PO Tablet
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 oral small molecule being studied for major depressive disorder and for bipolar disorder I or II with a major depressive episode. It is in Phase 2 clinical development and has not been approved for any indication. It is being developed by Alto Neuroscience, Inc.
ALTO-100 targets BDNF, or brain-derived neurotrophic factor. BDNF is a protein involved in neuronal growth, survival, and synaptic plasticity, processes that are relevant to mood regulation. By acting on BDNF, ALTO-100 is designed to address impaired neuroplasticity associated with depressive symptoms in major depressive disorder and bipolar depression.
ALTO-100 is being developed by Alto Neuroscience, Inc., which trades on the ticker ANRO. The company is the sponsor of the clinical program evaluating the drug in major depressive disorder and bipolar disorder with a major depressive episode.
ALTO-100 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The program includes completed Phase 2 studies in major depressive disorder and an ongoing Phase 2 trial in bipolar disorder with depression.
ALTO-100 has been studied in four Phase 2 trials. NCT06656416 is a recruiting Phase 2 trial in bipolar disorder with depression in the United States and United Kingdom. Completed trials include NCT05712187 in major depressive disorder, NCT05419869, a pilot decentralized MDD trial, and NCT05117632 in MDD and/or PTSD.
Yes. ALTO-100 PO Tablet and ALTO-100 PO tablet are alternative names for ALTO-100, referring to the oral tablet formulation of the drug. Searches for either name refer to the same investigational compound being developed by Alto Neuroscience, Inc. for major depressive disorder and bipolar depression.