Alzheimer's Disease Clinical Trial
Official title:
A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease
| Verified date | November 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.
| Status | Completed |
| Enrollment | 402 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening. - Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization Exclusion Criteria: - Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia. - Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations. - Evidence or history of diabetes mellitus Type 1 or Type 2. - History or symptoms of autoimmune disorders. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Beachwood | Ohio |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Grand Rapids | Michigan |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Irvine | California |
| United States | Pfizer Investigational Site | Irvine | California |
| United States | Pfizer Investigational Site | Irvine | California |
| United States | Pfizer Investigational Site | Irvine | California |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Madison | Wisconsin |
| United States | Pfizer Investigational Site | Madison | Wisconsin |
| United States | Pfizer Investigational Site | Martinez | California |
| United States | Pfizer Investigational Site | Miami Beach | Florida |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Newport Beach | California |
| United States | Pfizer Investigational Site | North Charleston | South Carolina |
| United States | Pfizer Investigational Site | Orange | California |
| United States | Pfizer Investigational Site | Palo Alto | California |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Providence | Rhode Island |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Sun City | Arizona |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Vista | California |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Alzheimer's Disease Cooperative Study (ADCS) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment. | 18 Month | ||
| Primary | Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI). | 18 Month | ||
| Secondary | Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET) | 18 Month | ||
| Secondary | Evaluate the potential dose response of PF 04494700 | 18 Month | ||
| Secondary | Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints | 18 Month |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Withdrawn |
NCT03316898 -
A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease
|
Phase 1 | |
| Withdrawn |
NCT02860065 -
CPC-201 Alzheimer's Disease Type Dementia: PET Study
|
Phase 2 | |
| Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
| Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
| Recruiting |
NCT05607615 -
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
|
Phase 2 | |
| Terminated |
NCT03307993 -
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
|
Phase 1 | |
| Recruiting |
NCT02912936 -
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
|
N/A | |
| Active, not recruiting |
NCT02899091 -
Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02907567 -
Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT02868905 -
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
|
N/A | |
| Terminated |
NCT02521558 -
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
|
N/A | |
| Completed |
NCT02516046 -
18F-AV-1451 Autopsy Study
|
Phase 3 | |
| Completed |
NCT02580305 -
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
|
Phase 2 | |
| Recruiting |
NCT02247180 -
Cognitive Rehabilitation in Alzheimer`s Disease
|
N/A | |
| Completed |
NCT02317523 -
Alzheimer's Caregiver Coping: Mental and Physical Health
|
N/A | |
| Terminated |
NCT02220738 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
|
Phase 1 | |
| Completed |
NCT02260167 -
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
|
N/A | |
| Completed |
NCT02256306 -
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
|
N/A | |
| Not yet recruiting |
NCT01940952 -
Zydena on Cognitive Function of Alzheimer's Disease Patients
|
Phase 3 |