Clinical trial NCT06895525: Efficacy of HellenCare in Early-Stage Alzheimer's Disease
Official title: The HEART Study: A Randomized, Double-Blind, Parallel Placebo-Controlled Trial on the Efficacy of HellenCare in Early-Stage Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer's Disease Dementia
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 investigators will compare changes in outcomes between the HellenCare group and the placebo group to determine if the intervention is effective and safe.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline
timeFrame: Baseline to three months
Secondary outcomes:
measure: Changes in Mini-Mental State Examination (MMSE) Scores from Baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in Neuropsychiatric Inventory (NPI) from Baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living（ADCS-ADL）from baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in Geriatric Depression Scale (GDS) from Baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in Self-Rating Anxiety Scale (SAS) from Baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in Self-Rating Depression Scale (SDS) from Baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in Self-Rating Scale of Sleep (SRSS) from Baseline
timeFrame: Up to Day 90 (including baseline and follow-up visits).
measure: Changes in plasma biomarker levels from baseline
timeFrame: Baseline to three months
measure: Safety and Tolerability
timeFrame: Up to Day 90 (including baseline and follow-up visits).
Other outcomes:
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