Trial record 2 of 3 for:
PF-04494700
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Trans Tech Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141661
First received: August 30, 2005
Last updated: August 19, 2009
Last verified: August 2009
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Purpose
A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: PF-04494700 - Low Dose Arm Drug: PF-04494700 - High Dose Arm Drug: Placebo Comparator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety Measures include Adverse Events [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]
- Laboratory Tests [ Time Frame: Every Office Visit ] [ Designated as safety issue: Yes ]
- 12-Lead Electrocardiogram [ Time Frame: Every Office Visit ]
- 24-Hour 12-Lead Serial ECGs [ Time Frame: Baseline, Study End ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta [ Time Frame: Baseline, Visit 5, Study End ] [ Designated as safety issue: No ]
- Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL [ Time Frame: Screening Visit, Baseline, Study End ] [ Designated as safety issue: No ]
- Pharmacokinetic Profile [ Time Frame: Baseline and Every Office Visit ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Low Dose Arm |
Drug: PF-04494700 - Low Dose Arm
30 mg loading dose for 6 days, followed by 10 mg daily
|
| Experimental: High Dose Arm |
Drug: PF-04494700 - High Dose Arm
60 mg loading dose for 6 days, followed by 20 mg daily
|
| Placebo Comparator: Placebo Control |
Drug: Placebo Comparator
Matching placebo.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of probably Alzheimer's disease for at least 1 year.
- Mini Mental State Exam (MMSE) score between 12-26 at screening.
- Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.
Exclusion Criteria:
- Current evidence of a neurological or psychiatric illness that could contribute to dementia.
- Living alone.
- Poorly controlled high blood pressure.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141661
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141661
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Pfizer Investigational Site | |
| Fresno, California, United States, 93720 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92103 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94118 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Fort Lauderdale, Florida, United States, 33321 | |
| Pfizer Investigational Site | |
| Fort Myers, Florida, United States, 33912 | |
| Pfizer Investigational Site | |
| Hallandale Beach, Florida, United States, 33009 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Largo, Florida, United States, 33773 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| Pfizer Investigational Site | |
| West palm Beach, Florida, United States, 33407 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
Sponsors and Collaborators
Pfizer
Trans Tech Pharmaceuticals
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00141661 History of Changes |
| Other Study ID Numbers: | B0341008, TTP488-201 |
| Study First Received: | August 30, 2005 |
| Last Updated: | August 19, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Interventional, Alzheimer, Safety and Tolerability |
ClinicalTrials.gov processed this record on March 03, 2015