Efficacy of HellenCare in Early-Stage Alzheimer's Disease

Официальное название

The HEART Study: A Randomized, Double-Blind, Parallel Placebo-Controlled Trial on the Efficacy of HellenCare in Early-Stage Alzheimer's Disease

Обзор

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.

Вмешательства

• Пищевая добавка HellenCare
  2 g, twice daily, to be taken on an empty stomach.
• Пищевая добавка Placebo
  2 g, twice daily, to be taken on an empty stomach.

Первичные конечные точки

• Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline [Срок оценки: Baseline to three months]

Вторичные конечные точки (10)

• Changes in Mini-Mental State Examination (MMSE) Scores from Baseline [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]
• Changes in Montreal Cognitive Assessment (MoCA) Scores from Baseline [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]
• Changes in Neuropsychiatric Inventory (NPI) from Baseline [Срок оценки: 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 [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]
• Changes in Geriatric Depression Scale (GDS) from Baseline [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]
• Changes in Self-Rating Anxiety Scale (SAS) from Baseline [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]
• Changes in Self-Rating Depression Scale (SDS) from Baseline [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]
• Changes in Self-Rating Scale of Sleep (SRSS) from Baseline [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]
• Changes in plasma biomarker levels from baseline [Срок оценки: Baseline to three months]
• Safety and Tolerability [Срок оценки: Up to Day 90 (including baseline and follow-up visits).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06895525 · NBJ-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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