Phase 1 N=88 Randomized Quadruple-blind Treatment

Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01193608 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Feb 2017

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 5; 3; 10; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: AAB-003 (PF-05236812) (Drug); Placebo (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	5; 3; 10; 8; 16; 12	—
PRIMARY Number of Participants With Laboratory Abnormalities	3; 3; 11; 10; 12; 13	—
PRIMARY Number of Participants With Vital Signs of Potential Clinical Concern	0; 0; 1; 0; 1; 0	—
PRIMARY Number of Participants With Abnormal Physical Examination Findings	2; 4; 1; 5; 9; 9	—
PRIMARY Number of Participants With Abnormal Neurological Examination Findings	1; 2; 2; 3; 1; 6	—
PRIMARY Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1	13.79; 32.05; 58.74; 122.4; 223.7	—
PRIMARY Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26	14.53; 38.51; 60.17; 108.5; 228.9	—
PRIMARY Average Concentration (Cavg) for AAB-003 in Serum at Day 1	2.465; 6.545; 10.83; 20.37; 36.78	—
PRIMARY Average Concentration (Cavg) for AAB-003 in Serum at Week 26	3.435; 7.171; 12.56; 22.52; 46.12	—
PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1	1.92; 4.00; 1.54; 1.50; 3.02	—
PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26	1.56; 2.00; 1.64; 2.00; 1.50	—
PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1	5397; 13470; 22960; 44000; 79130	—
PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1	5597; 13060; 25270; 46430; 82140	—
PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1	5384; 14300; 23660; 44490; 80320	—
PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26	7502; 15660; 27440; 49180; 100700	—
PRIMARY Systemic Clearance (CL) for AAB-003 in Serum at Day 1	0.08934; 0.07657; 0.07914; 0.08615; 0.09739	—
PRIMARY Systemic Clearance (CL) for AAB-003 in Serum at Week 26	0.06665; 0.06385; 0.07289; 0.08133; 0.07943	—
PRIMARY Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1	78.44; 59.74; 61.67; 60.44; 75.12	—
PRIMARY Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26	54.66; 48.27; 56.90; 65.11; 61.24	—
PRIMARY Serum Decay Half-Life (t1/2) for AAB-003 at Day 1	27.77; 20.04; 24.45; 21.10; 22.89	—
PRIMARY Serum Decay Half-Life (t1/2) for AAB-003 at Week 26	23.41; 22.32; 22.83; 22.27; 22.81	—
PRIMARY Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	0; 0; 1; 0; 1; 2	—
PRIMARY Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding	0; 0; 0; 0; 5; 0	—
PRIMARY Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit	0; 0; 0; 0; 1; 0	—
PRIMARY Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria	0; 0; 0; 0; 0; 0	—

Summary

This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.

Eligibility Criteria

Inclusion Criteria

Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria

Significant neurological disease other than Alzheimer's Disease
Major psychiatric disorder
Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
Women of childbearing potential

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01193608). 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.