Status:
NOT_YET_RECRUITING
Efficacy of HellenCare in Early-Stage Alzheimer's Disease
Lead Sponsor:
Peking University First Hospital
Conditions:
Alzheimer's Disease Dementia
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate whether HellenCare, a multicomponent nutraceutical, improves cognitive and functional outcomes in patients with early-stage Alzheimer's disease (AD). The...
Eligibility Criteria
Inclusion
- Participants aged 50 to 85 years
- Clinically diagnosed for the first time with probable Alzheimer's disease dementia (AD dementia) or AD-related mild cognitive impairment (MCI) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria.
- MMSE (Mini-Mental State Examination): Score between 22 and 30.
- CDR (Clinical Dementia Rating): Total score of 0.5 or 1. Memory domain score on CDR: ≥0.5.
- Able to comply with study procedures and attend scheduled visits.
- Willingness to participate and provide informed consent.
Exclusion
- Presence of other dementia-causing conditions (e.g., vascular dementia, Lewy body dementia, etc)
- Severe neurological comorbidities (e.g., history of seizures, cerebral infarction, intracerebral hemorrhage, traumatic brain injury, brain tumors, etc.)
- Presence of severe anxiety, depression, schizophrenia, bipolar disorder, or other psychotic disorders requiring active treatment.
- History of alcohol or drug dependence within the past 1 year.
- Allergies to study dietary supplement.
- Use of anti-dementia medications ( e.g., donepezil, galantamine, memantine, etc).
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06895525
Start Date
April 15 2025
End Date
December 31 2025
Last Update
April 8 2025
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