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

• Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05908695
• Collaborator: (none)
• Enrollment: 1,312
• Locations: 28
• Arms: 2
• Anticipated Duration (Months): 77
• Patients Per Site: 46.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: GV-971; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2029
• Anticipated Study Completion Date: Dec 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GV-971	Drug: GV-971; Administered PO
Placebo Comparator: Placebo	Drug: Placebo; Administered PO

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

3. 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.

4. 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.

Other Outcome Measures

1. Change from baseline on A-beta protein of CSF [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 [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 [Baseline, 36 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anding Hospital, Capital Medical University	Beijing	Beijing	China
2	Beijing Hospital	Beijing	Beijing	China
3	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China
4	The First Affiliated Hopsital of Xiamen University	Xiamen	Fujian	China
5	The First Affiliated Hopsital of Guangzhou Medical University	Guangzhou	Guangdong	China
6	The Second Affiliated Hopsital of Guangzhou Medical University	Guangzhou	Guangdong	China
7	The First People's Hospital of Nanning	Nanning	Guangxi	China
8	Shijiazhuang People's Hospital	Shijiazhuang	Hebei	China
9	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
10	The Second Hopsital of Hebei Medical University	Shijiazhuang	Hebei	China
11	Tangshan Workers' Hospital	Tangshan	Hebei	China
12	The First Affiliated Hopsital of Nanyang Medical College	Nanyang	Henan	China
13	Henan Provincial People's Hospital	Zhengzhou	Henan	China
14	Chenzhou First People's Hospital	Chenzhou	Hunan	China
15	Yueyang Central Hospital	Yueyang	Hunan	China
16	Huai'an Second People's Hospital	Huai'an	Jiangsu	China
17	Nanjing Brain Hospital	Nanjing	Jiangsu	China
18	Affiliated Hospital of Nantong University	Nantong	Jiangsu	China
19	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China
20	Yangzhou First People's Hospital	Yangzhou	Jiangsu	China
21	Jiujiang University Affiliated Hospital	Jiujiang	Jiangxi	China
22	The Second Affiliated Hopsital of Nanchang University	Nanchang	Jiangxi	China
23	The First Bethune Hospital of Jilin University	Changchun	Jilin	China
24	Qilu Hospital of Shandong University	Jinan	Shandong	China
25	Shandong Provincial Hospital	Jinan	Shandong	China
26	Yantai Yuhuangding Hospital	Yantai	Shandong	China
27	Tianjin People's Hospital	Tianjin	Tianjin	China
28	The Second Hospital of Jiaxing	Jiaxing	Zhejiang	China

Sponsors and Collaborators

• Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05908695
• Other Study ID Numbers: GV-971-PoCT
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jun 18, 2023