A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease (GREEN MEMORY)

• ClinicalTrials.gov Identifier: NCT04520412
• Recruitment Status: Suspended
• First Posted: August 20, 2020
• Last Update Posted: November 23, 2022
• Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Information provided by (Responsible Party): Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Tracking Information

• First Submitted Date: August 11, 2020
• First Posted Date: August 20, 2020
• Last Update Posted Date: November 23, 2022
• Actual Study Start Date: October 27, 2020
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2020)

• Change from baseline in the ADAS-cog/11 score [ Time Frame: 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.
• Change from baseline in the ADCS-CGIC score [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 18, 2020)

• Change from baseline in NPI score [ Time Frame: 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.
• Change from baseline in MMSE score [ Time Frame: 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 [ Time Frame: 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 NPI caregiver items [ Time Frame: 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 ZBI score [ Time Frame: 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 [ Time Frame: 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.
• Assess the efficacy of GV-971 throughout the OLE period [ Time Frame: Baseline, 52 Weeks, 78 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 18, 2020)

• Evaluate the population PK [ Time Frame: 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 [ Time Frame: Baseline, 52 Weeks ]
  Changes from baseline in volumetric magnetic resonance imaging (MRI)

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease
• Official Title: A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alzheimer Disease

Intervention

• Drug: GV-971
  Administered PO
• Drug: Placebo
  Administered PO

Study Arms

• Experimental: GV-971
  Intervention: Drug: GV-971
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: August 18, 2020): 2046
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2026
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, China, Czechia, France, Hong Kong, Netherlands, Poland, Taiwan, United States

Administrative Information

• NCT Number: NCT04520412
• Other Study ID Numbers: GV971-007
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Original Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Current Study Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Original Study Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Collaborators: Not Provided

Investigators

• Study Director: Study Director, Ph D; Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

• PRS Account: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Verification Date: November 2022