ProdromeNeuro: An Open-Label Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
Aging-related cognitive decline may be affected by brain cholesterol and the health of cell membranes. Certain nutritional supplements have been proposed to support membrane health, and there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support brain health among older adults. The product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among subjects with age-related cognitive decline.
详细描述
There has been an increasing interest in plasmalogens as a potential therapeutic agent for age-related cognitive decline and neurodegenerative conditions, given the growing understanding of their involvement in key cellular functions as well as the clinical trends observed when plasmalogen levels are depleted. In addition to supporting the structural integrity of membranes, these plasmalogens are also involved in a variety of critically important cell functions: membrane fusion, ion transport, vesicle formation, and oxidation-reduction. Plasmalogen and serum plasmalogen deficiency has been shown to impair cellular functions, particularly related to cholesterol processing, and has been implicated in Alzheimer's and other diseases. Plasmalogen precursor supplementation has been demonstrated as safe and potentially efficacious in preclinical studies and some patient populations. In theory, ProdromeNeuro supplementation may yield therapeutic benefits among patients with age-related cognitive decline by increasing levels of neuroprotective plasmalogens.
The present study is being undertaken as an open-label study to evaluate the safety and tolerability of ProdromeNeuro Omega-3 Oil as an intervention for patients with age-related cognitive decline. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. Neurocognitive assessment and serology testing kits to evaluate for plasmalogen levels will also be administered at baseline, end of the first month, end of the second month, end of the 3 month, and after one month post treatment termination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Cognitive decline due to aging-related changes
- •Clinical Dementia Rating stage of mild dementia 0.5 through moderate dementia CDR stages 1 and 2
排除标准
- •Subjects unable to give informed consent
- •Cognitive decline clearly related to an acute illness
- •Subjects taking anticoagulants and anti-platelet agents
- •Advanced terminal illness
- •Any active cancer or chemotherapy
- •Any other neoplastic illness or illness characterized by neovascularity
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: Baseline
The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status.
30 Second Sit-Stand (30CST)
时间窗: Baseline
The 30-second chair stand involves recording the number of times that a person can complete a full stand in 30 seconds. This measure assesses functional lower extremity strength in older adults. The participant is instructed to complete as many full stands as possible within 30 seconds, starting in a seated position in the middle of an armless chair. The participant is instructed to fully sit between each stand. The tester silently counts the completion of each correct stand, and the score is the total number of stands within 30 seconds. The minimum clinically important difference (MCID) is 2 full stands per 30 second testing.
Quick Dementia Rating Scale (QDRS)
时间窗: Baseline
The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).
Timed 25-foot Walk Test (T25FW)
时间窗: Baseline
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25-foot walk. Scoring for this task is the average number of steps (from first step to the first heel-strike after the finish line) and time taken (seconds/milliseconds) of two trials. Minimally clinically important difference (MCID) is 20% improvement in time taken and/or number of steps taken to complete.
9 Hole Pegboard Task (9 HPT)
时间窗: Baseline
A validated assessment for fine motor skills, the 9-HPT involves having a participant move 9 pegs individually from starting position to 9 separate peg-holes, as quickly as possible, and to immediately return the 9 pegs to the starting position upon filling the final peg-hole. This is performed separately for each hand. The score is the time (seconds/milliseconds) that it takes to complete the task, recorded separately for dominant and non-dominant hands. The minimum detectable change is 2.6 seconds for the dominant hand and 1.3 seconds for the non-dominant hand.
次要结局
- QDRS(End of Month 4)
- T25FW(End of Month 4)
- MoCA(End of Month 4)
- 30CST(End of Month 4)
- 9HPT(End of Month 4)