NCT06895525尚未招募不适用
The HEART Study: A Randomized, Double-Blind, Parallel Placebo-Controlled Trial on the Efficacy of HellenCare in Early-Stage Alzheimer's Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •CDR (Clinical Dementia Rating): Total score of 0.5 or
- •Memory domain score on CDR: ≥0.
- •Able to comply with study procedures and attend scheduled visits.
- •Willingness to participate and provide informed consent.
排除标准
- •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).
研究组 & 干预措施
HellenCare
Experimental
干预措施: HellenCare (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in Clinical Dementia Rating-Sum of Boxes (CDR-SB) from baseline
时间窗: Baseline to three months
CDR-SB range 0-18, with higher scores indicating more severe dementia.
次要结局
- 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).)
- Changes in Self-Rating Anxiety Scale (SAS) from Baseline(Up to Day 90 (including baseline and follow-up visits).)
- Changes in Self-Rating Depression Scale (SDS) from Baseline(Up to Day 90 (including baseline and follow-up visits).)
- Changes in Self-Rating Scale of Sleep (SRSS) from Baseline(Up to Day 90 (including baseline and follow-up visits).)
- Changes in plasma biomarker levels from baseline(Baseline to three months)
- Safety and Tolerability(Up to Day 90 (including baseline and follow-up visits).)
研究者
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