A Phase 2 Study to Evaluate the Efficacy and Safety of BPN14770 in Participants with Mild Alzheimer's Disease

JRCT ID: jRCT2031210149

Registered date:14/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: mild Alzheimer's disease
• Date of first enrollment: 29/06/2021
• Target sample size: 200
• Study type: Interventional
• Intervention(s): oral administration of BPN14770 or placebo

Outcome(s)

• Primary Outcome: Change from baseline in ADAS-Cog 13 score at Week 24

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

Participants who meet the criteria for probable AD dementia according to the Alzheimer's disease diagnostic criteria by National Institute on Aging-Alzheimer's Association (NIA-AA) and also meet the following criteria resulting in a clinical diagnosis of mild Alzheimer's disease.
1. CDR global score of 0.5 or 1 with a memory score of >= 0.5 at screening and prior to administration of study intervention.
2. MMSE score of 20 to 26 at screening.

• Exclude criteria: Any medical or neurological condition (other than mild Alzheimer's disease) that might have been a contributing cause to the participant's cognitive impairment, including Lewy body dementia and frontotemporal dementia.

Related Information

• Primary Sponsor: Nagata - Tsutae