Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04360365 · 7 trials · 1 indication
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported.
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI.
Quantitative amyloid imaging was performed using PET technique using \[11C\] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42).
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
Only participants received PF-04360365 were analyzed for this outcome measure.
| Arm | Type | Description |
|---|---|---|
| PF-04360365 10 mg/kg | EXPERIMENTAL | - |
| PF-04360365 7.5 mg/kg | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| PF-04360365 0.1 mg/kg | EXPERIMENTAL | - |
| PF-04360365 0.5 mg/kg | EXPERIMENTAL | - |
| PF-04360365 1 mg/kg | EXPERIMENTAL | - |
| PF-04360365 3 mg/kg | EXPERIMENTAL | - |
| PF-04360365 8.5 mg/kg | EXPERIMENTAL | - |
| PF-04360365 | EXPERIMENTAL | - |
| PF-04360365 5 mg/kg | EXPERIMENTAL | - |
| 0.1 mg/kg | EXPERIMENTAL | - |
| 0.5 mg/kg | EXPERIMENTAL | - |
| 1 mg/kg | EXPERIMENTAL | - |
| 5 mg/kg | EXPERIMENTAL | - |
| 10 mg/kg | EXPERIMENTAL | - |
| Active treatment | EXPERIMENTAL | 5 possible active doses |
| Name | Type | Description |
|---|---|---|
| PF-04360365 10 mg/kg | BIOLOGICAL | 10 mg/kg every 90 days (5 total doses) |
| PF-04360365 7.5 mg/kg | BIOLOGICAL | 10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses) |
| placebo | DRUG | placebo administered every 90 days or monthly to match experimental treatment arms. |
| PF-04360365 0.1 mg/kg | BIOLOGICAL | 0.1 mg/kg every 60 days (10 doses total) |
| PF-04360365 0.5 mg/kg | BIOLOGICAL | 0.5 mg/kg every 60 days (10 doses total) |
| PF-04360365 1 mg/kg | BIOLOGICAL | 1 mg/kg every 60 days (10 doses total) |
| PF-04360365 3 mg/kg | BIOLOGICAL | 3 mg/kg every 60 days (10 doses total) |
| PF-04360365 8.5 mg/kg | BIOLOGICAL | 8.5 mg/kg every 60 days (10 doses total) |
| PF-04360365 | BIOLOGICAL | 10 mg/kg, single dose administered intravenously |
| PF-04360365 5 mg/kg | BIOLOGICAL | PF-04360365 5 mg/kg infused as a single dose |
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 Associatio...
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PF-04360365 is an investigational monoclonal antibody that was studied for the treatment of mild to moderate Alzheimer's disease. It was developed by Pfizer and tested in clinical trials, but it is not an approved therapy. All of its recorded trials have been completed.
PF-04360365 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trial program for this monoclonal antibody in Alzheimer's disease.
PF-04360365 reached Phase 2 in clinical development. It is an investigational monoclonal antibody and is not approved for any indication. Seven trials have been completed, and none are currently active.
PF-04360365 has been studied in seven completed trials, including NCT01125631, NCT01005862, NCT00945672, and NCT00733642. These trials enrolled patients with mild to moderate Alzheimer's disease, and one also included healthy volunteers. Total enrollment across the program was 331 participants.