Phase 2 Alzheimer's Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with probable Alzheimer's disease (AD) based on recognised international diagnostic guidelines (NIA-AA 2011)
- People whose memory and thinking test scores (called MMSE) fall between 5 and 22 at the time treatment begins, indicating a moderate to moderately severe stage of the condition
- People who have been showing signs of agitation, as defined by the International Psychogeriatric Association (IPA), for at least 14 days before the screening period starts
- People whose agitation and aggression symptoms score 4 or higher on a specific nursing home behavioural assessment tool (NPI-NH) at the time treatment begins
- People who are able to stay in hospital from 21 days before the treatment period begins and throughout the entire treatment period
Who may not be able to join:
- People whose dementia is caused by something other than Alzheimer's disease, such as mixed dementia, vascular dementia, Lewy body dementia, Parkinson's-related dementia, frontotemporal dementia, drug-induced dementia, HIV-related dementia, traumatic brain injury, normal pressure hydrocephalus, or other non-Alzheimer's forms of dementia
- People whose brain MRI or CT scan (taken after dementia began) shows significant brain conditions unrelated to Alzheimer's disease, such as strokes, multiple areas of reduced blood flow, brain tumours, or other major structural brain abnormalities
- People who have experienced delirium (a sudden state of serious confusion) within the 30 days before screening begins, or who have a history of delirium
- People who show signs of being at risk of suicide based on a standard assessment tool (C-SSRS), who have made a suicide attempt in the 6 months before screening, or who are considered by the study doctor to be at serious risk of suicide
- People who are currently receiving, or have previously received, anti-amyloid beta antibody treatments (a type of medication targeting a protein involved in Alzheimer's disease)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Project Leader, Ono Pharmaceutical Co., Ltd.
Phone: +18665877745(Toll-Free)
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in CMAI score from baseline; Adverse events; Body weight; Body temperature; Blood pressure; Pulse rate; Respiratory rate; ECG RR interval; ECG PR interval; ECG QRS complex; ECG QT interval; ECG QTcF; Number of participants with abnormal laboratory tests (hematology); Number of participants with abnormal laboratory tests (Clinical chemistry); Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR)); Number of participants with abnormal Urinalysis; COLUMBIA-SUICIDE SEVERITY RA...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.