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Not yet recruitingNCT06895525Updated Apr 8, 2025

Efficacy of HellenCare in Early-Stage Alzheimer's Disease

An interventional study of HellenCare and Placebo in Alzheimer's Disease Dementia, sponsored by Peking University First Hospital. Not yet recruiting. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease Dementia
03

In context

Lead sponsor

Peking University First Hospital is the lead sponsor of 386 studies on the registry; 182 are open to participants now.

Browse Peking University First Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    HellenCare

    Dietary Supplement: HellenCare

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementHellenCare

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

  • Dietary supplementPlacebo

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

06

What researchers measure

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).

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. Changes in plasma biomarker levels from baseline

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

    Time frame: Baseline to three months

  10. Safety and Tolerability

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

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2025; primary completion for Dec 2025, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2025
First posted
Mar 26, 2025
StartEst.
Apr 15, 2025
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06895525
Lead sponsor
Peking University First Hospital
Responsible party
Sponsor
First posted
Mar 26, 2025
Start date
Apr 15, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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