Alzheimer's Disease THErapy With NEuroaid II
ConditionAlzheimer's Disease Dementia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorMoleac Pte Ltd.
About this trial
ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of MLC901 in subjects with mild to moderate Alzheimer's disease, as well as its effects on plasma biomarkers compared to placebo.
Eligibility criteria
Qualifiers
Male or female subjects aged ≥ 50 years at the time of providing informed consent.
Diagnosis of AD based on the National Institute on Ageing and the Alzheimer's Association (NIA-AA) criteria, supported by the presence of a Core 1 AD biomarker, specifically elevated plasma ptau217 ≥0.471 pg/mL.
MMSE score between 10 and 26, inclusive, at baseline, corresponding to mild to moderate AD.
Subjects may be either treatment-naïve or currently receiving stable symptomatic treatment for AD for at least the 2 months prior to screening, including AChEIs, memantine, or a combination of both.
Disqualifiers
Presence of any neurological disorder contributing to cognitive impairment other than AD, including but not limited to: Parkinson's disease, Dementia with Lewy bodies, and epilepsy or recurrent seizures.
Evidence of other clinically significant cerebrovascular disease or intracranial abnormalities based on the latest brain CT or MRI, including but not limited to: multiple lacunar infarcts, large territorial infarcts, severe small vessel or white matter disease, normal pressure hydrocephalus, space occupying lesions.
Presence of any serious or unstable medical illnesses, including but not limited to: cardiovascular, respiratory, gastroenterological, endocrinologic, immunologic, hematologic, hepatic, or renal and other conditions, that, in the investigator's judgment, may interfere with study participation or compromise subject safety.
Patients with a CDR Global Score of 0, 0.5 or 3 at the Screening Phase, corresponding to no, very mild or severe dementia, respectively, will be excluded from the study.
Trial design
Treatments tested in this trial
- MLC 901
- Placebo
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Moleac Pte Ltd.
Lead sponsor
National University Hospital, Singapore
Collaborator
Source ClinicalTrials.gov