Alzheimer's Disease DementiaNCT06895525
Efficacy of HellenCare in Early-Stage Alzheimer's Disease
A study testing HellenCare in people with Alzheimer's Disease Dementia, run by Peking University First Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease Dementia
- What is being tested?
- HellenCare
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: 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.
- Conditions
- Alzheimer's Disease Dementia
- Being tested
- HellenCare, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HellenCareDietary supplement
2 g, twice daily, to be taken on an empty stomach.
PlaceboDietary supplement
2 g, twice daily, to be taken on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| HellenCare | Experimental | Not described Receives: Dietary Supplement: HellenCare |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline
CDR-SB range 0-18, with higher scores indicating more severe dementia.
Measured: Baseline to three months
Secondary outcomes (10)
Changes in Mini-Mental State Examination (MMSE) Scores from Baseline
MMSE range 0-30, with higher scores indicating better cognitive functioning.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline to three months
Safety and Tolerability
The adverse event, discontinuation due to intolerability, etc will be monitored.
Measured: Up to Day 90 (including baseline and follow-up visits).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease DementiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895525
- Sponsor's protocol ID
- NBJ-01
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HEART Study: A Randomized, Double-Blind, Parallel Placebo-Controlled Trial on the Efficacy of HellenCare in Early-Stage Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06895525
- Acronym / sponsor ID
- NBJ-01
- Conditions
- Alzheimer's Disease Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HellenCare | Experimental | Dietary Supplement: HellenCare |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HellenCare2 g, twice daily, to be taken on an empty stomach. | Dietary supplement | HellenCare |
| Placebo2 g, twice daily, to be taken on an empty stomach. | Dietary supplement | Placebo |
Primary outcome
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.
10 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HellenCare in people with Alzheimer's Disease Dementia, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline (time frame: Baseline to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.