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

Alzheimer's Disease Clinical Trial

Official title:

A Multicenter, Open-label Extension, Multiple Dose, Parallel Group Study To Investigate The Long-term Safety And Tolerability Of Aab-003 (Pf-05236812) Administered Intravenously In Subjects With Mild To Moderate Alzheimer's Disease Previously Treated With Aab-003 Or Placebo In Protocol B2601001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369225
• Other study ID #: B2601003
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2011
• Last updated: September 26, 2014
• Start date: July 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AAB-003 (PF-05236812)
0.5 mg/kg AAB-003, IV
• AAB-003 (PF-05236812)
1 mg/kg AAB-003, IV
• AAB-003 (PF-05236812)
2 mg/kg AAB-003, IV
• AAB-003 (PF-05236812)
4 mg/kg AAB-003, IV
• AAB-003 (PF-05236812)
8 mg/kg AAB-003, IV

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital, Department of Neurology	Incheon
Korea, Republic of	Seoul National University Bundang Hospital, Department of Neurology	Seongnam-si	Gyeonggi-do
Korea, Republic of	ASAN Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center, Department of Neurology	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center, Department of Neurology	Seoul
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Foers Medical Arts Pharmacy	Bethesda	Maryland
United States	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri
United States	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	MD Clinical	Hallandale Beach	Florida
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	KNI Southwest Michigan Imaging Center, LLC	Kalamazoo	Michigan
United States	Central Jersey Radiology	Oakhurst	New Jersey
United States	Advanced Imaging of Ocala	Ocala	Florida
United States	Franck's Pharmacy	Ocala	Florida
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	CBH Health, LLC	Rockville	Maryland
United States	DePaul Health Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").	52 weeks	Yes
Primary	Electrocardiogram (ECG)	Measure incidence, frequency and severity of ECG abnormal findings	52 weeks	Yes
Primary	MRI	Measure incidence, frequency and severity of MRI abnormal findings	52 weeks	Yes
Secondary	The presence of anti-product antibodies to AAB-003 will be determined in serum		52 weeks	Yes
Secondary	Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)		52 weeks	No
Secondary	Disability Assessment in Dementia (DAD)		52 weeks	No
Secondary	Neuropsychiatric Inventory (NPI)		52 weeks	No
Secondary	Clinical Demential Rating Sum of Boxes (CDR-SB)		52 weeks	No
Secondary	Mini Mental State Exam (MMSE)		52 weeks	No
Secondary	CSF abeta, tau, p-tau, AAB-003 concentrations		52 weeks	No
Secondary	Plasma abeta concentrations and associated parameters (eg, Cmax, Tmax, AUClast, AUCinf, t1/2, as appropriate)		52 weeks	No

External Links

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