Efficacy of HellenCare in Early-Stage Alzheimer's Disease

Peking University

Status

Not yet enrolling

Conditions

Alzheimer's Disease Dementia

Treatments

Dietary Supplement: Placebo

Dietary Supplement: HellenCare

Study type

Interventional

Funder types

Other

Identifiers

NCT06895525

NBJ-01

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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).