Effect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid
NCT00987220
ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | ||||
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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 |
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Intervention |
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Study Groups/Cohorts |
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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 | 12 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Pfizer | |||
Verification Date | February 2011 |