Efficacy of HellenCare in Early-Stage Alzheimer's Disease

NCT06895525 | Not Yet Recruiting

• 1 other identifier: NBJ-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer's Disease Dementia

Outcome Measures

Primary Outcomes (1)

• Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline

  CDR-SB range 0-18, with higher scores indicating more severe dementia.

  Baseline to three months

Secondary Outcomes (10)

• Changes in Mini-Mental State Examination (MMSE) Scores from Baseline

  Up to Day 90 (including baseline and follow-up visits).

• Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline

  Up to Day 90 (including baseline and follow-up visits).

• Changes in Neuropsychiatric Inventory (NPI) from Baseline

  Up to Day 90 (including baseline and follow-up visits).

• Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living（ADCS-ADL）from baseline

  Up to Day 90 (including baseline and follow-up visits).

• Changes in Geriatric Depression Scale (GDS) from Baseline

  Up to Day 90 (including baseline and follow-up visits).

Study Arms (2)

HellenCare

EXPERIMENTAL

Dietary Supplement: HellenCare

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

HellenCare DIETARY_SUPPLEMENT

2 g, twice daily, to be taken on an empty stomach.

HellenCare

Placebo DIETARY_SUPPLEMENT

2 g, twice daily, to be taken on an empty stomach.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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).

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03