Efficacy of HellenCare in Early-Stage Alzheimer's Disease
ConditionAlzheimer's Disease Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HellenCare
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov