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Tests treatment safety and results for Alzheimer's Disease
Official title An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
ClinicalTrials.gov ID: NCT05908695
What this study is testing
What is GV-971?
GV-971 is an investigational medicine, being studied as a potential treatment for alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Huainan, Anhui, China
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Tangshan, Hebei, China
- Nanyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Chenzhou, Hunan, China
- Yueyang, Hunan, China
- Huai'an, Jiangsu, China
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Xuzhou, Jiangsu, China
- Yangzhou, Jiangsu, China
- Jiujiang, Jiangxi, China
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huainan, Anhui, China; Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Nanning, Guangxi, China and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.