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

NCT00744978 | Completed Phase 2 Results DMC

• 1 other identifier: A3051101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 8

Brief Summary

1. 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. 2.Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
3. 3.Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
4. 4.Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.

Conditions

Alzheimer's Disease

Keywords

Efficacy; Safety; Pharmacokinetics; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6

  12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.

  Week 6

Secondary Outcomes (21)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3

  Week 3

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3

  Week 3

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6

  Week 6

• Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6

  Week 6

• Neuropsychiatric Inventory (NPI) Total Score at Week 3

  Week 3

Study Arms (2)

Varenicline

EXPERIMENTAL

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Varenicline DRUG

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

Also known as: Chantix, Champix

Varenicline

Placebo DRUG

Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Pfizer Investigational Site

Seongnam, Gyunggido, 463-707, South Korea

Location

Pfizer Investigational Site

Busan, 602-715, South Korea

Location

Pfizer Investigational Site

Daegu, 700-721, South Korea

Location

Pfizer Investigational Site

Incheon, 400-711, South Korea

Location

Pfizer Investigational Site

Seoul, 136-705, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Seoul, 158-710, South Korea

Location

Pfizer Investigational Site

Suwon, 443-721, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24247022 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 22, 2011
• Results First Posted: November 22, 2011

Record last verified: 2011-10

Locations

KR (8)