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Not yet recruiting NCT06895525

Efficacy of HellenCare in Early-Stage Alzheimer's Disease

No phase Interventional Alzheimer's Disease Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HellenCare, Placebo.
Who it may be relevant to
Registry conditions: Alzheimer's Disease Dementia. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Dietary supplement HellenCare
    2 g, twice daily, to be taken on an empty stomach.
  • Dietary supplement Placebo
    2 g, twice daily, to be taken on an empty stomach.

Primary outcome measures

  • Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline [Time frame: Baseline to three months]
Secondary outcome measures (10)
  • Changes in Mini-Mental State Examination (MMSE) Scores from Baseline [Time frame: Up to Day 90 (including baseline and follow-up visits).]
  • Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline [Time frame: Up to Day 90 (including baseline and follow-up visits).]
  • Changes in Neuropsychiatric Inventory (NPI) from Baseline [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 [Time frame: Up to Day 90 (including baseline and follow-up visits).]
  • Changes in Geriatric Depression Scale (GDS) from Baseline [Time frame: Up to Day 90 (including baseline and follow-up visits).]
  • Changes in Self-Rating Anxiety Scale (SAS) from Baseline [Time frame: Up to Day 90 (including baseline and follow-up visits).]
  • Changes in Self-Rating Depression Scale (SDS) from Baseline [Time frame: Up to Day 90 (including baseline and follow-up visits).]
  • Changes in Self-Rating Scale of Sleep (SRSS) from Baseline [Time frame: Up to Day 90 (including baseline and follow-up visits).]
  • Changes in plasma biomarker levels from baseline [Time frame: Baseline to three months]
  • Safety and Tolerability [Time frame: Up to Day 90 (including baseline and follow-up visits).]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06895525 · NBJ-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗