Phase 1
Completed N=52
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT01369225 ↗Enrolled (actual)
52
Serious AEs
15.4%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 5; 3; 9; 5 participants
Summary
This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
5; 3; 9; 5; 10; 8 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern |
3; 2; 8; 7; 10; 6 | — |
| PRIMARY Number of Participants With Potentially Clinically Important Vital Sign Findings |
1; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Physical Examination Findings |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings |
1; 0; 0; 2; 0; 0 | — |
| PRIMARY Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings |
1; 1; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Successful completion of study B2601001
- MMSE 12 or greater
Exclusion Criteria
- Study B2601001 Week 32 MRI with clinically important exclusionary findings.
- Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
Data sourced from ClinicalTrials.gov (NCT01369225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.