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OpenTrials
Active, not recruiting

NCT Number: NCT05181475

Long-term Efficacy and Safety Study of GV-971

Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Beijing Chao-Yang Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 50 to 85 years (inclusive), with no restriction on gender;
  • Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
  • Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
  • Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;
  • Patients receiving GV-971 treatment prescribed by clinicians;
  • Sign the informed consent form.

Exclusion criteria

  • Patients who have received GV-971 treatment within 6 months prior to screening;
  • Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
  • Female participants who are pregnant or lactating;
  • Patients who cannot cooperate to complete the follow-up inquiries;
  • Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Treatment and study plan

Sodium Oligomannate Capsules (GV-971)

Drug

Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.

Primary outcomes

  1. Change from baseline in the ADAS-cog/11 score

    Time frame: Baseline, 48 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.

Secondary outcomes

  1. Change from baseline in ADAS-Cog/11 score

    Time frame: Baseline, 96 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 MMSE score

    Time frame: Baseline, 48 weeks, 96 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-ADL score

    Time frame: Baseline, 48 weeks, 96 weeks

    Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 48 weeks, 96 weeks

    The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971.

Sponsors and collaborators

Lead sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2022
Registry last updated
Nov 15, 2024

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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