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

Alzheimer's Disease Clinical Trial

Official title:

A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of AAB-003 (PF-05236812) In Subjects With Mild To Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193608
• Other study ID #: B2601001
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2010
• Last updated: November 19, 2013
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Other:
• Placebo
Placebo, IV

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Incheon
Korea, Republic of	Pfizer Investigational Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Bethesda	Maryland
United States	Pfizer Investigational Site	Creve Coeur	Missouri
United States	Pfizer Investigational Site	Eatontown	New Jersey
United States	Pfizer Investigational Site	Edison	New Jersey
United States	Pfizer Investigational Site	Escondido	California
United States	Pfizer Investigational Site	Flowood	Mississippi
United States	Pfizer Investigational Site	Hallandale Beach	Florida
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Oakhurst	New Jersey
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	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").	Week 39	Yes
Primary	MRI findings	Type, frequency and severity of MRI abnormal findings for each participant	Week 39	Yes
Primary	Electroardiogram (ECG)	Type, frequency and severity of ECG abnormal findings for each participant	Week 39	Yes
Primary	Standard Pharmacokinetic parameters for AAB-003	Measure Pharmacokinetic parameters for AAB-003: CMax, CAvg, TMax,AUClast, AUCinf, CLss, V, t1/2 from serum concentration of study drug	Week 39	No
Secondary	The presence of anti-product antibodies to AAB-003 will be determined in serum		Week 39	Yes
Secondary	Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)		Week 39	No
Secondary	Disability Assessment in Dementia (DAD)		Week 39	No
Secondary	Neuropsychiatric Inventory (NPI)		Week 39	No
Secondary	Clinical Dementia Rating Sum of Boxes (CDR-SB)		Week 39	No
Secondary	Mini Mental State Exam (MMSE)		Week 39	No
Secondary	CSF concentration of AAB-003		Week 32	No
Secondary	CSF amyloid-beta, tau, p-tau concentrations		Week 32	No
Secondary	Plasma amyloid-beta x-40 parameters (eg, Cmax, Tmax, AUClast, AUCinf, AUCtau, T1/2		Week 39	No

External Links

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