Alzheimer's disease
Conditions
Interventions
Experiment group:FMT capsules intervention
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of AD (2011 NIA-AA) and is diagnosed as mild AD (CDR=0.5 or 1, MMSE=18-27, with Aß pathology confirmed by Aß-PET); 2. Male and female subjects aged 60-80 years; 3. Able to take medication orally; 4. Have reliable and stable caregivers (contact with the subject at least 4 days per week for at least 2 hours per day) who are able to help subject in participation in this study; 5. Hachinski Ischemic Scale (HIS) total score <= 4 points; 6. Volunteer to be subjects and complete an informed consent form by him/her or his/her representatives.
Exclusion criteria
Exclusion criteria: 1. Unable to accomplish cognitive assessment scales due to inadequate vision, hearing, reading and writing skills, etc.; 2. Unable to undergo the imaging examinations due to allergy to 18F florbetapir or 11C-PIB or other reasons; 3. Use of antibiotics, probiotics, or other therapy that modulating gut microbiota within last 1 month before the screening visit; 4. Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before the screening visit; 5. Mixed dementia, vascular dementia, metabolic or mental disease related cognitive disorders; 6. Have severe neurological disorders such as Parkinsons disease, epilepsy, stroke, etc.; 7. Have severe psychiatric disorders, such as schizophrenia, depression, etc.; 8. Have severe gastrointestinal problems (e.g. life-threatening intestinal obstruction, perforation and bleeding, intestinal superinfection, etc.); 9. Have suffered from malignancy, chronic organ failure and other serious illnesses within 5 years; 10. History of severe allergic history, immunodeficiency disease, and other immune system diseases; 11. History of alcohol or drug abuse within 2 years before the screening visit; 12. Active or previous (within 1 month) participation in another clinical trial; 13. Positive serologic findings for HIV antibody; 14. Female patients who are in pregnancy, delivery or breastfeeding period; 15. Could not complete follow-up, or other factors that influence the compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) 13; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical dementia rating (CDR) -sum of box;Clinician’s interview-based impression of change plus (CIBIC+);Neuropsychiatric inventory questionnaire (NPI);Alzheimer's disease cooperative study-activities of daily living (ADCS-ADL) scale;Minimum mental state examination (MMSE);Montreal cognitive assessment (MoCA);Self-rating anxiety scale;Geriatric depression scale;Cytokines levels in bood;Immune cells levels in blood; | — |
Countries
China
Contacts
Public ContactWang Yanjiang
Army Medical Center of PLA (Daping hospital)
Outcome results
None listed