Alzheimer's Disease Dementia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHellenCare
2 g, twice daily, to be taken on an empty stomach.
DIETARY_SUPPLEMENTPlacebo
2 g, twice daily, to be taken on an empty stomach.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline | Baseline to three months | CDR-SB range 0-18, with higher scores indicating more severe dementia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline | Up to Day 90 (including baseline and follow-up visits). | MoCA range 0-30, with higher scores indicating better cognitive functioning. |
| Changes in Neuropsychiatric Inventory (NPI) from Baseline | Up to Day 90 (including baseline and follow-up visits). | 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. |
| Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living（ADCS-ADL）from baseline | Up to Day 90 (including baseline and follow-up visits). | ADCS-ADL range 0-78, with higher scores indicating better functional ability in daily activities. |
| Changes in Geriatric Depression Scale (GDS) from Baseline | Up to Day 90 (including baseline and follow-up visits). | 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. |
| Changes in Mini-Mental State Examination (MMSE) Scores from Baseline | Up to Day 90 (including baseline and follow-up visits). | MMSE range 0-30, with higher scores indicating better cognitive functioning. |
| Changes in Self-Rating Depression Scale (SDS) from Baseline | Up to Day 90 (including baseline and follow-up visits). | The SDS has a range of 20-80, with higher scores indicating more severe depressive symptoms. |
| Changes in Self-Rating Scale of Sleep (SRSS) from Baseline | Up to Day 90 (including baseline and follow-up visits). | The SRSS has a range of 10-50, with higher scores indicating more severe sleep problems. |
| Changes in plasma biomarker levels from baseline | Baseline to three months | The plasma biomarkers include Aβ42/40，p-tau181, p-tau217, NfL and GFAP |
| Safety and Tolerability | Up to Day 90 (including baseline and follow-up visits). | The adverse event, discontinuation due to intolerability, etc will be monitored. |
| Changes in Self-Rating Anxiety Scale (SAS) from Baseline | Up to Day 90 (including baseline and follow-up visits). | The SAS has a range of 20-80, with higher scores indicating more severe anxiety symptoms. |
Outcome results
None listed