Efficacy and Safety of Donepezil and Sodium Oligomannate in Patients With Mild to Moderate Alzheimer's Disease

NCT05114499 | Unknown

• 1 other identifier: XJTU1AF2021LSK-328
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Alzheimer's disease (AD) is the main cause of dementia. At present, AD is incurable. Cholinesterase inhibitors, especially donepezil, are the first choice for mild and moderate AD. Sodium oligomannate (GV-971) is a marine-derived oligosaccharide. It is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. It reduces Aβ deposition in the brain of Aβ-transgenic mice. The reduction in both Aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. The State Food and Drug Administration of China (SFDA) approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of cholinesterase inhibitor and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. They are also used in patients with AD, but there is a lack of data on their effectiveness and safety. Therefore, the purpose of this observational study is to compare the efficacy and safety of donepezil and GV-971 monotherapy and combination therapy in patients with mild and moderate AD, which is of great significance for guiding the treatment of mild and moderate AD.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• cognitive function

  the change of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score from baseline at week 36

  baseline, week 12, week 24, week 36

Study Arms (3)

Donepezil monotherapy group

Donepezil 5mg qd

Drug: Donepezil

GV-971 monotherapy group

GV-971 450mg bid

Drug: GV-971

Donepezil combined with GV-971 group

Donepezil 5mg qd+GV-971 450mg bid

Drug: Donepezil; Drug: GV-971

Interventions

Donepezil DRUG

Donepezil 5mg qd

Donepezil combined with GV-971 group; Donepezil monotherapy group

GV-971 DRUG

GV-971 450mg bid

Donepezil combined with GV-971 group; GV-971 monotherapy group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be enrolled from our memory clinic and in-patients and should meet the the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) (1984) criteria for probable AD.The diagnosis of AD is mainly based on detail clinical history from caregivers, neuropsychological testing, and brain MRI.

You may qualify if:

• age of 50-85 years old , either sex;
• met the diagnostic criteria for suspected AD;
• mild to moderate AD patients, that is, patients with 11 points ≤Mini-Mental State Examination(MMSE) total score ≤26 points
• total Hachinski ischemic scale (HIS) score ≤4 points;
• memory loss for at least 12 months, with a tendency of progressive deterioration;
• brain magnetic resonance imaging（MRI） scan suggesting a significant possibility of AD ;
• no obvious physical signs during nervous system examination;
• stable and reliable caregivers,
• elementary school or higher education level
• signed an informed consent form

You may not qualify if:

• previous nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
• mental illness according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition（DSM-IV), Text Revision criteria, including schizophrenia and other mental illness, bipolar disorder, and severe depression or paralysis;
• unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
• uncorrectable visual and auditory disorders that affected completing neuropsychological tests and scale assessments;
• simultaneous use of cholinesterase inhibitors or memantine.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil; GV-971

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Jin Wang, doctor

CONTACT

+86 29 85324033; drwangjin@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 10, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 10, 2021

Record last verified: 2021-11