Alzheimer Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.
Interventions
DRUGGV-971
Administered PO
DRUGPlacebo
Administered PO
Sponsors
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the ADCS-CGIC score | Baseline, 48 weeks and 52 weeks | Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. The total score of ADCS-CGIC is 1-7, with higher scores mean a worse outcome. |
| Change from baseline in the ADAS-cog/11 score | Baseline, 48 weeks and 52 weeks | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in MMSE score | Baseline, 52 Weeks | Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome. |
| Change from baseline in ADCS-ADL23 score | Baseline, 36 Weeks, 52 Weeks | Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ADCS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. |
| Change from baseline in ZBI score | Baseline, 52 Weeks | Change from baseline in Zarit Burden Interview (ZBI) score. The total score of ZBI is 0-88, with higher scores mean a worse outcome. |
| Assess the efficacy of GV-971 throughout the OLE period | Baseline, 52 Weeks, 78 Weeks | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome. |
| Change from baseline in NPI caregiver items | Baseline, 52 Weeks | Change from baseline in Neuropsychiatric Inventory (NPI) caregiver items . The total score of NPI caregiver items is 0-60, with higher scores mean a worse outcome. |
| Change from baseline in NPI score | Baseline, 36 Weeks, 52 Weeks | Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the population PK | Baseline, 12 Weeks, 24 Weeks, 52 Weeks | Determine serum levels of GV-971 in population PK |
| Evaluate the effect of GV-971 on brain structure neurodegeneration | Baseline, 52 Weeks | Changes from baseline in volumetric magnetic resonance imaging (MRI) |
Countries
Australia, Canada, China, Czechia, France, Hong Kong, Netherlands, Poland, Taiwan, United States
Outcome results
None listed