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ATH-1017 · 2 trials · 2 indications
ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1.
The Global Statistical Test (GST) score is a composite of cognition and function, calculated as the average of two change from baseline z-scores; the z-scores are calculated for the change from baseline scores for cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale \[ADAS-Cog11\]; lower value indicates improvement) and function (Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version \[ADCS-ADL23\] score; higher value indicates improvement). GST is a standardized score relative to the population mean. Therefore, a GST score of 0 is representative of the population mean. Since GST is a composite of two endpoints, a negative ADCS-ADL23 score is used in deriving GST. Therefore, a lower score indicates improvement, and a higher score indicates worsening. There are no defined clinically relevant thresholds for this GST score.
| Arm | Type | Description |
|---|---|---|
| Low Dose | EXPERIMENTAL | Daily subcutaneous (SC) injection of Low Dose ATH-1017 |
| High Dose | EXPERIMENTAL | Daily subcutaneous (SC) injection of High Dose ATH-1017 |
| Placebo | PLACEBO_COMPARATOR | Daily subcutaneous (SC) injection of Placebo |
| Dosage | EXPERIMENTAL | Daily subcutaneous (SC) injection of 40mg ATH-1017 |
| Name | Type | Description |
|---|---|---|
| ATH-1017 | DRUG | Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe |
| Placebo | DRUG | Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe |
Key Inclusion Criteria: * Age 55 to 85 years * Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening * Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011) * Reliable and capable support pers...
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ATH-1017 is an investigational small molecule being developed for the treatment of Alzheimer's disease, specifically for mild to moderate Alzheimer's disease and dementia of the Alzheimer type. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ATH-1017 is being developed by LeonaBio, Inc., a biopharmaceutical company traded under the ticker symbol LONA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Alzheimer's disease.
ATH-1017 is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total of 631 participants enrolled. The drug is investigational and has not received regulatory approval for any indication.
ATH-1017 has been studied in two completed Phase 2 trials: NCT04488419, which enrolled 554 participants in the United States, and NCT04491006, which enrolled 77 participants in the United States and Australia. Both trials were randomized, double-blind, and placebo-controlled, enrolling adults aged 55 years and older with mild to moderate Alzheimer's disease.
ATH-1017 is a distinct investigational drug developed by LeonaBio, Inc. No alternative names for ATH-1017 have been disclosed. It is a small molecule being evaluated specifically for Alzheimer's disease, and its mechanism of action has not been publicly detailed.