Phase II Study of a Nutraceutical on the Cognitive Performance of Older Adults.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Delay Eyeblink Conditioning
研究概览
简要总结
Interventions to improve the cognitive health of older adults are of critical importance. In the current protocol, ithe investigators conducted a short-term (two months) randomized clinical trial to examine the influence of the nutraceutical NT-020 on the cognitive performance of older adults. Participants were tested with a battery of cognitive tasks at baseline and two months after being randomized to the interventional drug or placebo.
详细描述
SUMMARY OF STUDY PLAN
The proposed clinical study is a Phase II, randomized, double-blinded, placebo-controlled trial in adults 65-85 years of age with no evidence of cognitive impairment. A total of 120 persons will be randomized to the study, with the goal of completing 100 evaluable subjects.
At the screening assessment, participants will complete the informed consent; questionnaires on basic demographic information including personal medical history and allergies to drug compounds; a mental ability test called the Mini-Mental Status Examination (MMSE); the SF-12 Health survey; the Centers for Epidemiologic Studies Depression Scale (CES-D) and distribute instructions and forms for diet survey and gastrointestinal questionnaires.
At the baseline/randomization assessment, study staff will (a) Confirm eligibility based on screening tests; (b) collect completed diet and gastrointestinal questionnaire survey forms; (c) collect blood for CBC/CMP and antioxidant biomarkers; (d) battery of cognitive tests including Rey Auditory Verbal Learning Test, Educational Testing Service - Identical Pictures Test, Educational Testing Service - Number Comparison Test, Educational Testing Service - Vocabulary Test, Trailmaking A & B, Wechsler Adult Intelligence Scale - Digit Symbol Test, Wechsler Intelligence Scale - Digit Span, Letter Fluency, Category Fluency. Subjects will be equally randomized (n=60 per arm) to blinded treatment with either NT-020 (Natura Therapeutics Nutrastem) or matching placebo, and an initial supply of study drug will be dispensed. Participants will be supplied with one-month supply of blinded treatment (n=60/arm) and be given the study agent intake and symptom log form. The planned intervention period is 2 months.
At specified intervals (weeks 1, 3, 5, 7), participants will be contacted to inquire about the correct administration of the supplement or placebo as well as to assess for any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 65-85 years of age (inclusive).
- •Able to understand and sign the informed consent.
- •Native English-speaking.
- •No evidence of dementia (MMSE >=23).
- •Each subject must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
- •All subjects must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice.
排除标准
- •Use of high dose antioxidant supplements other than what is provided in the trial.
- •History of known allergy to components of the study supplements.
- •Mental illness judged by the PI to preclude a successful completion of the trial.
- •Persons who are not native English speakers are excluded from the current proposal because many of the cognitive tests that are administered are language-based and are heavily influenced by first language.
- •Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
研究组 & 干预措施
NT-020
Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.
干预措施: NT-020 (Drug)
Placebo
Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Delay Eyeblink Conditioning
时间窗: Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses
Participants will be tested on eyeblink classical conditioning at the USF Health Byrd Alzheimer's Institute. Participants will receive 60 trials of eyeblink conditioning at the two-month follow-up point. Participants watch an entertaining silent video (e.g., Milo and Otis). The airpuff is delivered through a nozzle held in front of the participant and blink latency is recorded. The outcome measure is an index of the percentage of eyeblinks that are made to a tone (conditioned stimulus) after the learning period is complete. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned; Woodruff-Pak, D. S. (2001). Eyeblink classical conditioning differentiates normal aging from Alzheimer's disease. Integrative Physiological and Behavioral Science, 36(2), 87-108.).
次要结局
- Cognitive Performance(Measured at baseline and two months)