Efficacy of HellenCare in Early-Stage Alzheimer's Disease
NCT ID: NCT06895525
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HellenCare
HellenCare
2 g, twice daily, to be taken on an empty stomach.
Placebo
Placebo
2 g, twice daily, to be taken on an empty stomach.
Interventions
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HellenCare
2 g, twice daily, to be taken on an empty stomach.
Placebo
2 g, twice daily, to be taken on an empty stomach.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
50 Years
85 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Other Identifiers
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NBJ-01
Identifier Type: -
Identifier Source: org_study_id
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