The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,046
Change from baseline in the ADAS-cog/11 score
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.
Time frame: Baseline, 48 weeks and 52 weeks
Change from baseline in the ADCS-CGIC score
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.
Time frame: Baseline, 48 weeks and 52 weeks
Change from baseline in NPI score
Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.
Time frame: Baseline, 36 Weeks, 52 Weeks
Change from baseline in MMSE score
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.
Time frame: Baseline, 52 Weeks
Change from baseline in ADCS-ADL23 score
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.
Time frame: Baseline, 36 Weeks, 52 Weeks
Change from baseline in NPI caregiver items
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.
Time frame: Baseline, 52 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cognitive Clinical Trials, LLC
Gilbert, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Banner Alzheimer's Institute
Tucson, Arizona, United States
Irvine Clinical Research
Irvine, California, United States
Sunwise Clinical Research
Lafayette, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pacific Research Network, Inc
San Diego, California, United States
Pacific Research Network
San Diego, California, United States
...and 161 more locations
Change from baseline in ZBI score
Change from baseline in Zarit Burden Interview (ZBI) score. The total score of ZBI is 0-88, with higher scores mean a worse outcome.
Time frame: Baseline, 52 Weeks
Assess the efficacy of GV-971 throughout the OLE period
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.
Time frame: Baseline, 52 Weeks, 78 Weeks
Assess the efficacy of GV-971 throughout the OLE period
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.
Time frame: Baseline, 52 Weeks, 78 Weeks