NCT06895525Not yet recruiting
Efficacy of HellenCare in Early-Stage Alzheimer's Disease
The HEART Study: A Randomized, Double-Blind, Parallel Placebo-Controlled Trial on the Efficacy of HellenCare in Early-Stage Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Mar 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Peking University First Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT06895525
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Apr 2025 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.