Alzheimer's Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: AD patients: (1)Consistent with the NIA-AA determination of Alzheimer's disease-induced mild/moderate cognitive impairment;(2)Age >=50 years old, Male or Female;(3)Patients were informed and consented to participate in this study and agreed to attend all visits, examinations, and treatments as required by the study protocol. Control group: (1) No history of memory decline or other related cognitive impairment; (2) normal daily living ability; (3) MMSE scores: illiteracy >21, primary school culture >24, secondary school culture >27; (4) No imaging contraindications.
Exclusion criteria
Exclusion criteria: (1)Severe AD and cognitive impairment due to surgery or other reasons; (2)A history of inflammatory bowel disease, carbohydrate malabsorption, hormonal imbalance, known allergy to food additives, or any other serious medical condition; (3)History of gallbladder removal, gastrointestinal and cranial brain surgeries; (4)Parasitic infections; (5)Unable to cooperate with the study due to suicidal thoughts, attempts or aggressive behavior; (6)Use of medications known to affect gastrointestinal function, blood pressure and lipids, hormone supplements, allergy/asthma medications, proton pump inhibitors and over-the-counter medications; (7)use of probiotics or antibiotics or prebiotics (dietary fiber, oligosaccharides) within the 8 weeks prior to the trial; alcohol or drug abuse; (8)Patients with a history of major trauma; (9)Patients with moderate and severe malnutrition; (10)Patients with type 1 diabetes, Latent autoimmune diabetes in adults (LADA) and type 2 diabetes with fasting blood glucose greater than 10.11mmol/L; (11)Use of drugs with known ketogenic tendencies (such as SGLT2, etc.) (12)Patients who have received an organ transplant or have previously received a non-autologous (allogeneic) bone marrow or stem cell transplant; (13)Patients who have contraindications for cranial brain imaging such as post-steel plate placement, claustrophobia, etc.; or inability to cooperate with perfect imaging examination because of agitation, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale score of Minimum Mental State Examination (MMSE);Scale score of Montreal Cognitive Assessment (MoCA);Scale score of Clinical Dementia Rating-Sum of Boxes (CDR-SB); | — |
Secondary
| Measure | Time frame |
|---|---|
| Scale score of Activity of DailyLiving Scale (ADL);Peripheral blood AD biomarkers;blood lipid levels;Serum ketone body levels;Plasma metabolome levels;Gut microbiota;Brain glutamate levels; | — |
Countries
China
Contacts
Peking University Shenzhen Hospital