Efficacy of HellenCare in Early-Stage Alzheimer's Disease

N/ANot Yet RecruitingNCT06895525

Peking University First Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer's Disease Dementia

Interventions

HellenCareDIETARY_SUPPLEMENT

2 g, twice daily, to be taken on an empty stomach.

PlaceboDIETARY_SUPPLEMENT

2 g, twice daily, to be taken on an empty stomach.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline

CDR-SB range 0-18, with higher scores indicating more severe dementia.

Time frame: Baseline to three months

Secondary Outcomes

Changes in Mini-Mental State Examination (MMSE) Scores from Baseline

MMSE range 0-30, with higher scores indicating better cognitive functioning.

Time frame: Up to Day 90 (including baseline and follow-up visits).

Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline

MoCA range 0-30, with higher scores indicating better cognitive functioning.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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