A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT00945672 |
Recruitment Status :
Completed
First Posted : July 24, 2009
Last Update Posted : May 5, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Biological: PF-04360365 10 mg/kg Biological: PF-04360365 7.5 mg/kg Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Double-Blinded, Randomized, Placebo-Controlled, Multicenter Study Evaluating The Safety, Tolerability And Pharmacokinetics/ Pharmacodynamics Of PF-04360365 In Mild To Moderate Alzheimer's Disease Patients |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: PF-04360365 10 mg/kg |
Biological: PF-04360365 10 mg/kg
10 mg/kg every 90 days (5 total doses) |
Experimental: PF-04360365 7.5 mg/kg |
Biological: PF-04360365 7.5 mg/kg
10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses) |
Placebo Comparator: placebo |
Drug: placebo
placebo administered every 90 days or monthly to match experimental treatment arms. |
- Safety/tolerability/PK of multiple doses of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 1 year (adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments) [ Time Frame: 18 months ]
- Brain amyloid burden [ Time Frame: 13 months ]
- CSF abeta [ Time Frame: 13 months ]
- Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma abeta, CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; immunogenicity (anti-drug antibodies) [ Time Frame: 18 months ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females of non childbearing potential, age > or = 50.
-
Diagnosis of probable Alzheimer's disease, consistent with criteria from both:
- National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
- Diagnostic and Statistical Manual of Mental Disorders (DSM IV).
- Mini-mental status exam score of 16-26 inclusive.
- Rosen-Modified Hachinski Ischemia Score of < or = 4.
Exclusion Criteria:
- Diagnosis or history of other demential or neurodegenerative disorders.
- Diagnosis or history of clinically significant cerebrovascular disease.
- Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities.
- History of autoimmune disorders.
- History of allergic or anaphylactic reactions.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945672
Sweden | |
Pfizer Investigational Site | |
Göteborg, Sweden, 413 45 | |
Pfizer Investigational Site | |
Malmo, Sweden, 205 02 | |
Pfizer Investigational Site | |
Molndal, Sweden, 431 41 | |
Pfizer Investigational Site | |
Stockholm, Sweden, 141 86 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00945672 |
Other Study ID Numbers: |
A9951007 |
First Posted: | July 24, 2009 Key Record Dates |
Last Update Posted: | May 5, 2016 |
Last Verified: | June 2011 |
Alzheimer's disease amyloid imaging antibody |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |