NCT05908695|RecruitingPhase 4

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

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

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.ClinicalTrials.gov

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1 other identifier

GV-971-PoCT

Study Type

interventional

Target

1,312

Locations

1 country

Sites

Timeline

RegisteredJun 2023

StartedAug 2023

CompletionDec 2029

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,312

participants targeted

Target at P75+ for phase_4

Timeline

43mo left

Started Aug 2023

Longer than P75 for phase_4

Geographic Reach

1 country

50 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.3 years study duration

Study Progress44%

Aug 2023Dec 2029

First Submitted

Initial submission to the registry

May 31, 2023

Completed

18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed

2 months until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

5.8 years

First QC Date

May 31, 2023

Last Update Submit

November 8, 2023

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

Change from baseline in the ADAS-cog/12 score
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.
Baseline, 36 weeks
Change from baseline in ADCS-ADL23 score
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.
Baseline, 36 weeks

Secondary Outcomes (4)

Change from baseline in MMSE score
Baseline, 36 weeks
Change from baseline in the CIBIC-Plus score
Baseline, 36 weeks
Change from baseline in NPI score
Baseline, 36 weeks
Change from baseline in ADCS-ADL23 score
Baseline, 36 weeks

Other Outcomes (3)

Change from baseline on A-beta protein of CSF
Baseline, 36 weeks
Change from baseline on Tau protein of CSF
Baseline, 36 weeks
Change from baseline on biomarkers of Th1/Th2 cell subtypes
Baseline, 36 weeks

Study Arms (2)

GV-971

EXPERIMENTAL

Drug: GV-971

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GV-971DRUG

Administered PO

GV-971

PlaceboDRUG

Administered PO

Placebo

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Sites (50)

Huainan First People's Hospital

Huainan, Anhui, China

RECRUITING

Beijing Anding Hospital, Capital Medical University