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NCT Number: NCT05908695

An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Huainan First People's Hospital, Huainan, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GV-971

Drug

Administered PO

Placebo

Drug

Administered PO

Primary outcomes

  1. Change from baseline in the ADAS-cog/12 score

    Time frame: 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.

  2. Change from baseline in ADCS-ADL23 score

    Time frame: 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 outcomes

  1. Change from baseline in MMSE score

    Time frame: 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.

  2. Change from baseline in the CIBIC-Plus score

    Time frame: 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.

  3. Change from baseline in NPI score

    Time frame: 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.

  4. Change from baseline in ADCS-ADL23 score

    Time frame: 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 outcomes

  1. Change from baseline on A-beta protein of CSF

    Time frame: Baseline, 36 weeks

    Change from baseline on biomarkers of CSF A-beta protein after 36 weeks of treatment.

  2. Change from baseline on Tau protein of CSF

    Time frame: Baseline, 36 weeks

    Change from baseline on biomarkers of CSF Tau protein after 36 weeks of treatment.

  3. Change from baseline on biomarkers of Th1/Th2 cell subtypes

    Time frame: Baseline, 36 weeks

    Change from baseline on biomarkers of peripheral blood immune cell subtypes of Th1/Th2 after 36 weeks of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director, Ph. D

CONTACT

[email protected]

+86 21 50504988 ext. 8821

Sponsors and collaborators

Lead sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jun 18, 2023
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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