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Efficacy and Safety of Structured Multidomain Lifestyle Interventions in Alzheimer's Disease : A Multicenter, Prospective, Randomized Controlled Clinical Trial

Efficacy and Safety of Structured Multidomain Lifestyle Interventions in Alzheimer's Disease : A Multicenter, Prospective, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124029
Enrollment
Unknown
Registered
2026-05-06
Start date
2026-05-11
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

Intervention group:1. Multi-modal exercise training
2. Nutritional and dietary intervention
3. Music intervention
4. Health management
5. Cognitive training
6. Social activity intervention
7. Sleep improvement
Control group:conventional treatment

Sponsors

Tianjin Huanhu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 50~85 years, any gender; 2. Meet the core clinical criteria for AD dementia established by NIA-AA; 3. Plasma biomarkers (Aß42/40, p-tau217, etc.) support AD pathological changes or Aß-PET is positive; 4. Sedentary lifestyle; 5. Diet does not meet MIND diet requirements; 6. Have basic mobility and can complete moderate-intensity exercise under supervision; 7. Have a stable caregiver (contact >=3 days per week, >=2 hours per day) who can assist with follow-up visits and scale assessments; 8. Will not leave the intervention center for more than 3 months during the intervention period; 9. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Cognitive impairment not caused by Alzheimer's disease (such as vascular dementia, Lewy body disease, frontotemporal dementia, etc.); 2. History of severe neurological diseases (such as stroke, brain tumor, epilepsy, Parkinson's disease, etc.); 3. Major organ dysfunction, poorly controlled cardiovascular or cerebrovascular disease, or unstable metabolic disease; 4. Presence of contraindications to exercise or severe limitation in limb movement; 5. Suffering from severe mental illness or recent use of high doses of psychiatric medications; 6. Presence of contraindications to MRI scanning or inability to cooperate with neuropsychological assessment; 7. Caregiver unwilling to cooperate with research requirements.

Design outcomes

Primary

MeasureTime frame
ApoE gene;Mini-Mental State Examination Score;Montreal Cognitive Assessment Score;Clinical Dementia Rating Score;Advance-Decline Line Score;Hamilton Anxiety/Depression Scale Score;Neuropsychiatric Inventory Score;amyloid ß-protein;microtubule-associated protein tau;Neurofilamentlightchain;glial fibrillary acidic protein;

Countries

China

Contacts

Public ContactShuai Liu; Yong Ji

Tianjin Huanhu Hospital

jiyongusa@126.com+86 159 0225 5772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026