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

NCT05908695·50 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Medical Director, Ph. D
CONTACT
+86 21 50504988 xinxianliang@greenvalleypharma.com

Lead

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Age

50–85

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible 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 be 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.

The record

StatusRecruiting

PhasePhase 4

Taking part1,312

StartedAug 2023

UpdatedNov 9, 2023

Conditions

Alzheimer's Disease

Where50

Huainan First People's Hospital
Huainan, Anhui, China
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China