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NCT Number: NCT06895525

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.

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Key information

Conditions

Alzheimer's Disease Dementia

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

HellenCare

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

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

    Time frame: Baseline to three months

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

Secondary outcomes

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

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

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

  2. Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline

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

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

  3. Changes in Neuropsychiatric Inventory (NPI) from Baseline

    Time frame: 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.

  4. Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living（ADCS-ADL）from baseline

    Time frame: 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.

  5. Changes in Geriatric Depression Scale (GDS) from Baseline

    Time frame: 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.

  6. Changes in Self-Rating Anxiety Scale (SAS) from Baseline

    Time frame: 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.

  7. Changes in Self-Rating Depression Scale (SDS) from Baseline

    Time frame: 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.

  8. Changes in Self-Rating Scale of Sleep (SRSS) from Baseline

    Time frame: 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.

  9. Changes in plasma biomarker levels from baseline

    Time frame: Baseline to three months

    The plasma biomarkers include Aβ42/40，p-tau181, p-tau217, NfL and GFAP

  10. Safety and Tolerability

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

    The adverse event, discontinuation due to intolerability, etc will be monitored.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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