NCT06895525 · NOT YET RECRUITING
Efficacy of HellenCare in Early-Stage Alzheimer's Disease
This trial is testing HellenCare, a multicomponent nutraceutical supplement, to see whether it improves thinking and daily functioning in people with early-stage Alzheimer's disease or mild cognitive impairment. Participants either take HellenCare or a placebo, and researchers compare outcomes between the two groups. This is a Phase NA trial — meaning it sits outside the standard drug-approval phases, which is common for supplement studies.
You may qualify if
- 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.
You're excluded if
- 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).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-04-08