Clinical trial NCT00397891: Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmakokinetic Study of Single Ascending Doses of AAB-001 in Japanese Patients With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AD
* Age 50-85
* MMSE 14-26
* Other Inclusion Criteria Apply

Exclusion Criteria:

* Significant Neurological Disease
* Major Psychiatric Disorder
* Clinically Significant Systemic Illness
* Other Exclusion Criteria Apply

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 52
measure: Number of Participants With Clinically Significant Changes in Physical Examinations
timeFrame: Screening up to Week 52
measure: Number of Participants With Vital Signs of Potential Clinical Importance
timeFrame: Baseline up to Week 52
measure: Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance
timeFrame: Screening up to Week 16
measure: Number of Participants With Laboratory Test Results of Potential Clinical Importance
timeFrame: Week 1 up to Week 52
measure: Number of Participants With Clinically Significant Changes in Neurological Examinations
timeFrame: Screening up to Week 52
measure: Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Systemic Clearance (CL) of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Volume of Distribution at Steady State (Vss) of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Mean Residence Time of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Serum Decay Half-Life (t1/2) of Bapineuzumab
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
measure: Serum Bapineuzumab Concentrations
timeFrame: 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion
measure: Number of Participants With Positive Serum Anti-Bapineuzumab Antibody
timeFrame: Baseline (Day 1) up to Week 52
measure: Plasma Amyloid-beta (x-40) Concentrations
timeFrame: 0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Arai H, Umemura K, Ichimiya Y, Iseki E, Eto K, Miyakawa K, Kirino E, Shibata N, Baba H, Tsuchiwata S. Safety and pharmacokinetics of bapineuzumab in a single ascending-dose study in Japanese patients with mild to moderate Alzheimer's disease. Geriatr Gerontol Int. 2016 May;16(5):644-50. doi: 10.1111/ggi.12516. Epub 2015 Jun 4.