Efficacy of HellenCare in Early-Stage Alzheimer's Disease

The HEART Study: A Randomized, Double-Blind, Parallel Placebo-Controlled Trial on the Efficacy of HellenCare in Early-Stage Alzheimer's Disease

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 Overview

• Status: Not yet recruiting
• Conditions: Alzheimer's Disease Dementia
• Intervention / Treatment: Dietary supplement: HellenCare; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 2 g, twice daily, to be taken on an empty stomach.
Experimental: HellenCare	Dietary supplement: HellenCare; 2 g, twice daily, to be taken on an empty stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: NBJ-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No