Phase 2
Completed N=79
Study Evaluating Bapineuzumab In Alzheimer Disease Subjects
Source: ClinicalTrials.gov NCT00663026 ↗Enrolled (actual)
79
Serious AEs
7.6%
Results posted
Nov 2013
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 16; 22; 28; 1 participants
Summary
The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
16; 22; 28; 1; 2; 3 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
4219.97; 8012.88 | — |
| SECONDARY Average Serum Concentration at Steady State (Cavg,ss) |
3123.071; 6912.301 | — |
| SECONDARY Serum Decay Half-Life (t1/2) |
— | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) |
3696.00; 4200.00 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) |
524675.88; 1161266.63 | — |
| SECONDARY Apparent Systemic Clearance (CL/F) |
0.16; 0.132 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
- Mini-Mental State Examination (MMSE) score 16-26
Exclusion Criteria
- Magnetic Resonance Imaging (MRI) showing other brain abnormalities
- Other diagnosed neurological or psychiatric disorders
Data sourced from ClinicalTrials.gov (NCT00663026). 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.