| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04491006 | A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease | PHASE2 | COMPLETED | 77 | — | — | Nov 23, 2020 | May 20, 2022 | Jun 12, 2023 | 13 | United States, Australia |
| NCT04488419 | ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease | PHASE2 | COMPLETED | 554 | — | — | Sep 28, 2020 | Jul 15, 2024 | Apr 4, 2025 | 1 | United States |
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...