Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in
mild to moderate Alzheimer's disease.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
NeuroPsychology
Enrollment Eligibility
Inclusion Criteria:
- Mild to moderate AD per NIA-AA.
- History of cognitive and functional decline over at least 1 year.
- MMSE scores between 11 and 24 (inclusive) at baseline.
- Brain MRI scan show the highest possibility of AD.
- Have a study partner/caregiver.
Exclusion Criteria:
- Diagnosis of a dementia-related central nervous system disease other than AD.
- Major structural brain disease as judged by MRI.
- A resting heart rate of < 50 beats per minute (bpm) after 5 minutes of rest in sitting
or supine position.
- Major medical illness or unstable medical condition within 6 months of screening.
- Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, and
during the study.
- Inadequate hepatic function.
- Inadequate organ and marrow function.
- ECG clinically significant abnormalities.