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

NCT00987220

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease, Dementia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Alzheimer's Disease, DementiaEfficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
NCT00096473
  1. Northport, Alabama
  2. Phoenix, Arizona
  3. Sun City, Arizona
  4. Tucson, Arizona
  5. San Francisco, California
  6. Santa Monica, California
  7. Torrance, California
  8. Denver, Colorado
  9. Ft. Lauderdale, Florida
  10. Ft. Myers, Florida
  11. North Miami, Florida
  12. St. Petersburg, Florida
  13. Atlanta, Georgia
  14. Chicago, Illinois
  15. New Orleans, Louisiana
  16. Springfield, Massachusetts
  17. Long Branch, New Jersey
  18. Piscataway, New Jersey
  19. New Hyde Park, New York
  20. Greenville, North Carolina
  21. Raleigh, North Carolina
  22. Centerville, Ohio
  23. Oklahoma City, Oklahoma
  24. Medford, Oregon
  25. Portland, Oregon
  26. Jenkintown, Pennsylvania
  27. Austin, Texas
  28. Houston, Texas
  29. Randwick, New South Wales
  30. Brisbane, Queensland
  31. Woodville South, South Australia
  32. Heidelberg West, Victoria
  33. Nedlands, Western Australia
  34. Toronto, Ontario
  35. Paris,
  36. Belfast,
  37. St. Leonards on Sea, East Sussex
  38. West End, Southampton
  39. Swindon, Wilshire
  40. Bath,
  41. Blackpool,
  42. Bradford,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Alzheimer's Disease, DementiaEffect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid
NCT00987220
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
PRS Account Pfizer
Verification Date February 2011