A Clinical Trial in Mild to Moderate Alzheimer’s Disease — The ATH-1017-AD-0202 Study
Alzheimer’s disease is a neurodegenerative disorder that affects learning, memory, and other normal brain functions. Neurodegeneration is characterised as the progressive loss of structure or function of brain cells.
ATH-1017 is a new small molecule that has been shown in early research to enhance learning, memory and executive functions such as reasoning and planning. In addition, initial studies have found that ATH-1017 may work to promote increased growth and survival of brain cells which are usually damaged in Alzheimer’s disease.
This study medication has been developed as a subcutaneous (under the skin) daily injection.
To compare how well this drug works, participants will be randomly assigned to 3 different groups:
- 80 mg ATH-1017;
- 40mg ATH-1017;
- and placebo (1:1:1).
Therefore, all participants have a 2 in 3 chance of receiving the ATH-1017 active study drug.
This study will require participation for up to 35 weeks including 10 onsite visits during that period. A 26-week open-label extension where participants receive the active drug may be available upon completion of the study.
Main Inclusion criteria*:
- Age 55 to 85 years
- Clinical diagnosis of mild to moderate Alzheimer’s disease dementia
- Availability of a study partner who spends at least 4 to 6 hrs per day with participant, for at least 4 days a week
- If receiving medication for symptomatic Alzheimer’s Disease, the participant should have been on a stable approved dose for at least 3 months prior to the screening visit
*Please note: there are additional criteria that must be met in order to qualify to participate in this study.