A study of Sodium Oligomannate (GV-971) in participants with mild to moderate Alzheimer's disease
Information about the drug that will be tested in the study
Administration
The drug will be administered orally once daily.
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected at random to either receive one of the following options:
- An oral dose of GV-971
- An oral dose of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.
How long will the treatment last?
Around 1.5 year (12 visits to the study center and up to 6 telephone calls with the study team).
What your involvement will entail?
During the study,
- Participants will be asked to complete tests that will assess their cognition, functioning and (i.e. tests like ADCS-CGIC, ADAS-Cog)
- During the study, participants will have to complete some laboratory/biological tests (i.e., blood samples, ECG, heart rate)
- Participants will also need to complete some other questionnaires to evaluate their cognition, behaviour and function (e.g. NPI, MMSE)
- Participants will be asked to undertake brain scans (MRI) to see changes in biomarkers in the brain.
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be between 50 and 85 years old
- Have a diagnosis of mild to moderate Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
- Have a history of cognitive and functional decline over at least 1 year
- Have a score between11 and 24 in the MMSE test (a test about your memory. This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
- Have evidence of abnormal accumulation of amyloid in their brain (brain MRI scan)
- Have a study partner who has a sufficient contact with the participant is willing to participate in study procedures throughout the study duration.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Participant who have a diagnosis of a dementia-related central nervous system disease other than Alzheimer’s disease
- Brain scans showing significant abnormality
- Major medical illness or unstable medical condition within the past six months
- Use of approved symptomatic medication for dementia (i.e. donepezil, rivastigmine, galantamine or memantine) within the past 30 days.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
EudraCT Number
2020-001755-41
Clinicaltrials.gov identifier
NCT04520412
Study contact information
Link to full text
https://clinicaltrials.gov/ct2/show/NCT04520412
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on January 2022.
This document has not been reviewed by the pharmaceutical company running this trial.
This document has been reviewed by a member of the European Working Group of People with Dementia.
