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Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Seongnam, Gyunggido, 463-707 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females, age 55-85

- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1)
National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's
Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and
Statistical Manual of Mental Disorders (DSM IV)

- Mini-mental status exam score of 14-26 inclusive

- Rosen-Modified Hachinski Ischemia Score of

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

- Diagnosis or history of other dementia or neurodegenerative disorders

- Diagnosis or history of clinically significant cerebrovascular or cardiovascular
disease

- Subjects with pulmonary disease or evidence of clinically significant pulmonary
symptoms

NCT00744978
Pfizer
Completed
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease

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Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Crossover Trial of Varenicline Tartrate (CP-526,555) in Patients With Mild to Moderate Alzheimer's Disease
  1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease
  2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
  3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
  4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Varenicline
    0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks
    Other Name: Chantix, Champix
  • Drug: Placebo
    Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
  • Experimental: Varenicline
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Kim SY, Choi SH, Rollema H, Schwam EM, McRae T, Dubrava S, Jacobsen J. Phase II crossover trial of varenicline in mild-to-moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2014;37(3-4):232-45. doi: 10.1159/000355373. Epub 2013 Nov 14.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females, age 55-85
  • Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
  • Mini-mental status exam score of 14-26 inclusive
  • Rosen-Modified Hachinski Ischemia Score of < or = 4

Exclusion Criteria:

  • Diagnosis or history of other dementia or neurodegenerative disorders
  • Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease
  • Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms
Sexes Eligible for Study: All
55 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00744978
A3051101
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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