Efficacy of HellenCare in Early-Stage Alzheimer's Disease

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a supplement called HellenCare to see if it can help improve memory and daily functioning in people with early-stage Alzheimer's disease, a type of dementia that affects thinking and memory. The researchers will compare the results of those taking HellenCare with a group receiving a placebo, which is a dummy treatment that doesn’t contain the active ingredient. The goal is to find out if HellenCare is effective and safe for those with this condition.

To participate in the trial, individuals need to be between 50 and 85 years old and have recently been diagnosed with Alzheimer’s disease or mild cognitive impairment related to Alzheimer's. They should also have a certain level of cognitive function, as measured by a memory test. Participants must be willing to attend scheduled visits and follow the study's guidelines. It's important to note that people with other types of dementia, severe neurological issues, or certain mental health conditions won't be eligible for the study. If you or someone you know might be interested in participating, keep an eye out for updates on when the trial will start recruiting participants.

Gender

ALL

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).