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Effect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid

A Methodology Study To Evaluate Cerebrospinal Fluid Acetylcholine Following A Single Dose Administration Of Donepezil In Healthy Subjects

NCT00987220•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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.
+4 more criteria

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

February 1, 2010

Completion Date

February 1, 2010

Last Updated

February 14, 2011

Enrollment

ACTUAL participants

Conditions

Alzheimer's DiseaseDementia

Interventions

Placebo

DRUG

donepezil (Aricept)

DRUG

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NCT06159673

Alzheimer's Disease Psychosis

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NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid

Inclusion Criteria

Exclusion Criteria

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