Alzheimers disease
Conditions
Interventions
Observation group:Nove
GV-971 group (Task 3 Drug Intervention):Take 3 capsules (450mg) of Sodium Oligomannate at a time, twice daily.
VR Cognitive and Motor Training Group (Task 3 Non-pharmacological Intervention):Five days of VR cognitive exercise training per week, once a day, 30 minutes each time, for a total of 8 weeks.
DASH + Gluten-free Dietary Pattern Group (Task 3 Non-pharmacological Intervention):Adopt the DASH + gluten-free dietary pattern for a total of 8 weeks.
Sponsors
The Affiliated GuangdongSecond Provincial GeneralHospital of Jinan University
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: For Task 1 (Study on Natural History and Multifactorial Etiological Model of Preclinical AD) and Task 2 (Research on Digital Biomarkers and AI-based Community Screening Technologies): 1.Age >= 50 years; 2.Voluntary participation (or consent from a guardian) and signed informed consent form. For Task 3 (Intervention Study for Preclinical AD): 1.Positive for APP, PSEN1, or PSEN2 gene mutations; 2.Meets NIA-AA diagnostic criteria; 3.Meets diagnostic criteria for Mild Cognitive Impairment (MCI); 4.Age >= 50 years; 5.Signed informed consent form.
Exclusion criteria
Exclusion criteria: For Task 1 (Study on Natural History and Multifactorial Etiological Model of Preclinical AD) and Task 2 (Research on Digital Biomarkers and AI-based Community Screening Technologies): 1.History of non-AD dementia with clear etiology; 2.Comorbid severe psychological/psychiatric disorders (e.g., anxiety disorders, depression, schizophrenia) or significant mental abnormalities; 3.History of systemic diseases severely affecting daily living capacity; 4.Long-term use of psychotropic medications; 5.History of traumatic brain injury with sequelae; 6.Unwilling or unable to complete cognitive function assessments; 7.Incomplete clinical data collection; 8.Relevant nasal conditions (polyps, deviated septum, tumors, or trauma). For Task 3 (Intervention Study for Preclinical AD): 1.Dementia diagnosis post-baseline assessment; 2.Clear history of cerebrovascular stroke with corresponding imaging evidence of causative lesions; 3.Severe white matter lesions (Fazekas score =3); 4.Current psychiatric disorders; 5.History of alcohol abuse, drug addiction, or neurological conditions that may cause cognitive impairment (e.g., brain trauma, epilepsy, encephalitis); 6.Systemic diseases potentially causing mild cognitive impairment; 7.Abnormal laboratory test results; 8.Female subjects who are pregnant, breastfeeding, or planning pregnancy; 9.Concurrent participation in other clinical trials; 10.Use of cognition-affecting medications within 1 month prior to study initiation; 11.Contraindications for brain MRI or PET-CT imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AD nerve injury markers (Aß1-42, Aß1-40, p-tau-181, p-tau-231);Smell identification;Cognitive function ;Imaging indexes: 18F-FDG-PET and Aß PET, functional magnetic resonance;APOE e4 gene ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuroelectrophysiological indicators: polysomnography and electroencephalography;Facial expressions;Gait; | — |
Countries
China
Contacts
Public ContactPing Luan
The Affiliated GuangdongSecond Provincial GeneralHospital of Jinan University
Outcome results
None listed