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

Phase 4

Recruiting

• Conditions: Alzheimer's Disease
• Interventions: Drug: GV-971; Drug: Placebo

• Registration Number: NCT05908695
• Lead Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Study Start: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09
• Primary Completion: 2029-06
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1312

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GV-971	GV-971	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the ADAS-cog/12 score	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.
Change from baseline in ADCS-ADL23 score	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 Outcome Measures

Name	Time	Method
Change from baseline in the CIBIC-Plus score	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.
Change from baseline in ADCS-ADL23 score	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.
Change from baseline in MMSE score	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.
Change from baseline in NPI score	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.

Trial Locations

Locations (50)

Huainan First People's Hospital; 🇨🇳 Huainan, Anhui, China

Beijing Anding Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, Beijing, China

The First Medical Center, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hopsital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

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