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Trial record 1 of 1 for:    NCT00987220
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Effect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid

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ClinicalTrials.gov Identifier: NCT00987220
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : February 14, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date September 28, 2009
First Posted Date September 30, 2009
Last Update Posted Date February 14, 2011
Study Start Date October 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2009)
Mean post-dose vs predose change in CSF acetycholine levels in donepezil compared to placebo control group. [ Time Frame: 6 hrs ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00987220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 28, 2009)
Mean post-dose vs predose change in CSF histamine metabolites, sAPPalpha and inflammatory endpoints [ Time Frame: 6hrs ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid
Official Title A Methodology Study To Evaluate Cerebrospinal Fluid Acetylcholine Following A Single Dose Administration Of Donepezil In Healthy Subjects
Brief Summary It is hypothesized that the acetylcholinesterase inhibitor, donepezil, will increase acute cerebrospinal fluid (CSF) actylcholine levels in healthy volunteers following a 5mg single dose oral administration.
Detailed Description Sampling method based upon estimates of intra-subject biomarker variability.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, plasma, CSF
Sampling Method Non-Probability Sample
Study Population Young (18-55) male and female healthy volunteers.
Condition
  • Alzheimer's Disease
  • Dementia
Intervention
  • Drug: Placebo
    Oral
  • Drug: donepezil (Aricept)
    5mg oral
    Other Name: Aricept
Study Groups/Cohorts
  • Placebo
    Intervention: Drug: Placebo
  • donepezil (Aricept)
    Intervention: Drug: donepezil (Aricept)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2010)
12
Original Estimated Enrollment
 (submitted: September 28, 2009)
16
Actual Study Completion Date February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of approximately 18 to 33 kg/m2; and a total body weight >50 kg (110 lbs).
  • Subject has the ability to understand the requirements of the study, provide written informed consent, and abide by the requirements of the study.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • History of febrile illness within 5 days prior to the first study period.
  • History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • A positive urine drug screen at screening.
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first study period. As an exception, analgesics, caffeine, and non-pharmacological methods may be used on the discretion of the investigator to manage symptoms related to the lumbar catheterization. Aspirin, aspirin containing products, and non-steroidal anti-inflammatory agents that affect platelet function should not be used. Other exceptions may be granted by a qualified member of Pfizer study management.
  • Treatment with an investigational drug within 30 days preceding the first study period.
  • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception (as will be outlined in the protocol) from at least 14 days prior to enrollment in the study until completion of the study.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  • Subjects with papilledema on exam at screening or on Day 0.
  • Subject has any laboratory values outside the normal ranges on screening or on Day 0 which are deemed clinically significant by the investigator. Coagulation indices, including PT/aPTT, and platelet count must be normal.
  • Subjects with lower spinal malformations, local infection, or other abnormalities that would exclude lumbar puncture (LP).
  • Subjects who are unwilling or unable to comply with the Lifestyle guidelines presented in the protocol.
  • Other severe acute or chronic medical or psychiatric condition/status or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results, and in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00987220
Other Study ID Numbers A9001428
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2011