A Randomized, Double-Blind, Sponsor Unblinded, Placebo- And Positive- Controlled Study To Evaluate The Effects Of Single Oral Administrations Of PF-04995274, Alone Or In Combination With Donepezil, On Scopolamine-Induced Deficits In Psychomotor And Cognitive Function In Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Groton Maze Learning Test (Total Errors)
研究概览
简要总结
This study is designed to look at the potential for an investigational drug (PF-04995274, under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to reverse changes in memory and learning/problem solving skills caused by co-administration of a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory and learning/problem solving skills that are similar to those seen in people with alzheimer's disease(AD).
详细描述
Changes in sponsor's organizational strategy have led to the decision to terminate the study and therefore to not conduct the second cohort (Cohort B/arms 2 and 3) . This decision was not based on significant safety concerns. Date of termination (ie, the date the site was notified to stop study activities) was 12 Oct 2011.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers; females must be of non-childbearing potential.
- •Weight with normal limits for height.
- •Willing to comply with study schedule and able to complete 2 practice sessions (pre-study) with computerized memory and learning/problem solving tests.
排除标准
- •Positive urine drug screen; concurrent use of prescription or over-the-counter (OTC) drugs or dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication.
- •Use of medications with significant serotonergic, cholinergic or anticholinergic side effects [SSRIs, pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin]) within 4 weeks of first dose of study drug.
- •Abnormal electrocardiogram (ECG)
- •Treatment with an investigational drug within 30 days of dosing.
研究组 & 干预措施
Cohort A
Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
干预措施: Scopolamine + Donepezil Placebo + PF-04995274 Placebo (Drug)
Cohort A
Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
干预措施: Scopolamine + Donepezil 5 mg + PF-04995274 Placebo (Drug)
Cohort A
Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
干预措施: Scopolamine + Donepezil 10mg + PF-04995274 Placebo (Drug)
Cohort A
Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
干预措施: Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg (Drug)
Cohort A
Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
干预措施: Scopolamine + Donepezil Placebo + PF-04995274 15 mg (Drug)
结局指标
主要结局
Groton Maze Learning Test (Total Errors)
时间窗: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing
次要结局
- Detection Task (Speed; included in CogState test battery)(Day 1 of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing)
- Identification Task (Speed; included in CogState test battery)(Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing)
- One Card Learning Task (Accuracy of Performance; included in CogState test battery)(Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing)
- Bond-Lader Visual Analogue Scales(Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing)