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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HellenCare | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HellenCare | Dietary Supplement | 2 g, twice daily, to be taken on an empty stomach. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline | CDR-SB range 0-18, with higher scores indicating more severe dementia. | Baseline to three months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Mini-Mental State Examination (MMSE) Scores from Baseline | MMSE range 0-30, with higher scores indicating better cognitive functioning. | Up to Day 90 (including baseline and follow-up visits). |
| Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo |
| Dietary Supplement |
2 g, twice daily, to be taken on an empty stomach. |
|
MoCA range 0-30, with higher scores indicating better cognitive functioning. |
| Up to Day 90 (including baseline and follow-up visits). |
| Changes in Neuropsychiatric Inventory (NPI) from Baseline | NPI score range is 0-144 for patient assessment and 0-60 for caregiver distress assessment. In patient assessment, higher scores indicate more severe neuropsychiatric disorders; in caregiver distress assessment, higher scores indicate greater distress. | Up to Day 90 (including baseline and follow-up visits). |
| Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living（ADCS-ADL）from baseline | ADCS-ADL range 0-78, with higher scores indicating better functional ability in daily activities. | Up to Day 90 (including baseline and follow-up visits). |
| Changes in Geriatric Depression Scale (GDS) from Baseline | GDS is a standardized assessment tool for evaluating depressive symptoms in older adults, scored from 0 to 15, with higher scores indicating greater severity of depressive symptoms and associated functional impairment. | Up to Day 90 (including baseline and follow-up visits). |
| Changes in Self-Rating Anxiety Scale (SAS) from Baseline | The SAS has a range of 20-80, with higher scores indicating more severe anxiety symptoms. | Up to Day 90 (including baseline and follow-up visits). |
| Changes in Self-Rating Depression Scale (SDS) from Baseline | The SDS has a range of 20-80, with higher scores indicating more severe depressive symptoms. | Up to Day 90 (including baseline and follow-up visits). |
| Changes in Self-Rating Scale of Sleep (SRSS) from Baseline | The SRSS has a range of 10-50, with higher scores indicating more severe sleep problems. | Up to Day 90 (including baseline and follow-up visits). |
| Changes in plasma biomarker levels from baseline | The plasma biomarkers include Aβ42/40，p-tau181, p-tau217, NfL and GFAP | Baseline to three months |
| Safety and Tolerability | The adverse event, discontinuation due to intolerability, etc will be monitored. | Up to Day 90 (including baseline and follow-up visits). |