Efficacy of HellenCare in Early-Stage Alzheimer's Disease

Not Applicable

Not yet recruiting

• Conditions: Alzheimer's Disease Dementia

• Registration Number: NCT06895525
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Study Start: 2025-04-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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.