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

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ClinicalTrials.gov Identifier: NCT04520412
Recruitment Status : Suspended (The quality of study was seriously affected by the COVID-19, so it was decided to suspend the trial and restart it at the right time.)
First Posted : August 20, 2020
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: GV-971 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : October 2026

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GV-971 Drug: GV-971
Administered PO
Placebo Comparator: Placebo Drug: Placebo
Administered PO


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Other Outcome Measures:
  1. Evaluate the population PK [ Time Frame: Baseline, 12 Weeks, 24 Weeks, 52 Weeks ]
    Determine serum levels of GV-971 in population PK

  2. Evaluate the effect of GV-971 on brain structure neurodegeneration [ Time Frame: Baseline, 52 Weeks ]
    Changes from baseline in volumetric magnetic resonance imaging (MRI)


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520412


Locations
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Sponsors and Collaborators
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Study Director, Ph D Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04520412    
Other Study ID Numbers: GV971-007
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders