A Six-month, Double-blind, Placebo-controlled, Single Site Study of Cerefolin NAC on Blood Homocysteine, Oxidative Stress, and Beta-amyloid Biomarkers That May Potentiate Inflammation and Neuronal Damage in Older Individuals With Memory Complaints Who Have Not Been Clinically Diagnosed With Mild Cognitive Impairment, Vascular Dementia, or Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only
研究概览
简要总结
The purpose of this six-month research study is to determine if Cerefolin NAC reduces levels of substances in the blood that may be associated with thinking ability and the health of brain cells in subjects with memory concerns when compared to a standard multivitamin. Cerefolin NAC is available as a dietary supplement via a prescription from a physician. The multivitamin used in the study contains the Recommended Daily Intake recommended for older persons.
详细描述
Study Phase: Exploratory
Indication: Memory Complaints
Study Design:
A single-center, double-blind, placebo-controlled study with 100 subjects with memory complaints followed for 6 months (4 visits)using Cerefolin® NAC or placebo once a day in addition to a standardized multivitamin.
Sample Size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 60;
- •Memory complaints as defined by two questions:
- •"Do The subject think your have memory problems?"; and,
- •"Has there been a decline in your memory over the last 10 years?"
- •Fluency in English;
- •Ability to ingest oral medications; and,
- •Willing to replace current vitamin intake with a standardized multivitamin provided for the study.
排除标准
- •Clinical stroke or Parkinson's disease;
- •Taking FDA approved drug for symptomatic treatment of Alzheimer's disease (Aricept, Razadyne, Exelon, and/or Namenda);
- •History of significant renal insufficiency (creatinine ≥1.5);
- •History of renal stones or peptic ulcer disease;
- •Use of vitamin supplements containing more than 400mcg of folic acid per day within 2 months of Screen Visit;
- •As determined by the study physician, clinically significant serum folate and vitamin B12 deficiency on screening blood tests that would require further clinical evaluation and treatment
- •As determined by the study physician, clinically significant medical conditions, physical exam findings or abnormal blood tests at screening that would require further clinical evaluation and treatment
- •B12 injections 6 months prior to the Screen Visit;
- •Confirmed clinical diagnosis of Mild Cognitive Impairment (MCI), vascular dementia or Alzheimer's Disease (AD); and,
- •Known hypersensitivity to L-methylfolate, methyl-cobalamin or N-acetylcysteine.
- •Use of any other investigational agent used during the 30 days prior to Screening.
研究组 & 干预措施
1
On Cerefolin NAC and open-label multivitamin supplement
干预措施: Cerefolin NAC (a medical food) (Other)
2
On placebo and open label multivitamin supplement
干预措施: Cerefolin NAC placebo (Other)
结局指标
主要结局
Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only
时间窗: 6 months
Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aβ42 and Aβ40. Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method. Enzyme-linked immunosorbent assays (ELISA) were used for Aβ42 (Wako Chemicals USA, Inc., Richmond, VA) and Aβ40 (Invitrogen Corporation, Canarillo, CA) detection. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline. Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs). A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aβ42 to Aβ40 ratio) to declare the study positive.
次要结局
- Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only(6 months)
- Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only(6 months)
研究者
Raj C Shah
Assistant Professor, Family Medicine and Rush Alzheimer's Disease Center
Rush University Medical Center