Alzheimer's Disease
Conditions
Brief summary
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.
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. * Hachinski Ischemic Score (HIS) scale total score ≤ 4. * Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10. * Brain MRI scan show the highest possibility of AD. * Have a reliable study partner/caregiver. * Sign the informed consent form.
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 10 minutes of rest. * Major medical illness or unstable medical condition within 12 months of screening. * Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline. * Inadequate hepatic function. * Inadequate organ function. * ECG clinically significant abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the ADAS-cog/12 score | Baseline, 36 weeks | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome. |
| Change from baseline in ADCS-ADL23 score | Baseline, 36 weeks | Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the CIBIC-Plus score | Baseline, 36 weeks | Change from baseline on Clinician's Interview-Based Impression of Change Plus (CIBIC-Plus) scale total score. The total score of CIBIC-Plus is 1-7, with higher scores mean a worse outcome. |
| Change from baseline in MMSE score | Baseline, 36 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 NPI score | Baseline, 36 weeks | Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome. |
| Change from baseline in ADCS-ADL23 score | Baseline, 36 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on Tau protein of CSF | Baseline, 36 weeks | Change from baseline on biomarkers of CSF Tau protein after 36 weeks of treatment. |
| Change from baseline on A-beta protein of CSF | Baseline, 36 weeks | Change from baseline on biomarkers of CSF A-beta protein after 36 weeks of treatment. |
| Change from baseline on biomarkers of Th1/Th2 cell subtypes | Baseline, 36 weeks | Change from baseline on biomarkers of peripheral blood immune cell subtypes of Th1/Th2 after 36 weeks of treatment. |
Countries
China
Contacts
Primary ContactMedical Director, Ph. D
Outcome results
None listed