Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

Pfizer

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: AAB-003 (PF-05236812)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01369225

B2601003

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 5 patient groups

0.5 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

1 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

2 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

4 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

8 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

Trial contacts and locations

21

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