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Efficacy of HellenCare in Early-Stage Alzheimer's Disease

ConditionAlzheimer's Disease Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: HellenCareExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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).
2

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).
3

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).
4

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).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: