A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397578
• Other study ID #: ABE4955g
• Secondary ID: GN00762
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2011
• Last updated: July 10, 2017
• Start date: August 31, 2011
• Est. completion date: April 30, 2014

Study information

• Verified date: July 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 30, 2014
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria

• Mini-Mental State Examination (MMSE) score of 18-26 points at screening

• Geriatric Depression Scale (GDS-15) score of < 6

• Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)

• For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to randomization, at a stable dose for at least the last 2 months prior to randomization

Exclusion Criteria:

• Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care

• History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)

• History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)

• Hospitalization within 4 weeks prior to screening

• Previous treatment with MABT5102A or any other therapeutic that targets Abeta

• Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• MABT5102A
Repeating subcutaneous injection
• MABT5102A
Repeating intravenous infusion
• placebo
Repeating subcutaneous injection
• placebo
Repeating intravenous infusion

Locations

Country	Name	City	State
France	Hopital Central-CHU de Nancy; Pharmacie	Nancy
France	Hôpital Casselardit; Cons memoire	Toulouse
France	Clinique Psychiatrique Univ	Tours Cedex 9
Spain	Fundació ACE	BArcelon	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Mutua De Terrasa	Barcelona
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
United States	Dekalb Neurology Associates	Decatur	Georgia
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Alexian Brothers Neurosci Inst	Elk Grove Village	Illinois
United States	Internal Med Assoc of Lee Cty	Fort Myers	Florida
United States	Neuropsychiatric Research; Center of Southwest Florida	Fort Myers	Florida
United States	Margolin Brain Institute	Fresno	California
United States	MD Clinical	Hallandale Beach	Florida
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Cleveland Clinic Lou Ruvo; Center for Brain Research	Las Vegas	Nevada
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.	Manhasset	New York
United States	Compass Research	Orlando	Florida
United States	Pacific Neuroscience Med Grp	Oxnard	California
United States	Stanford Univ Medical Center	Palo Alto	California
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Butler Hospital	Providence	Rhode Island
United States	Redwood Regional Medical Group	Santa Rosa	California
United States	Banner Sun Health Research Insitute	Sun City	Arizona
United States	Neurology & Neuroscience Ctr of Ohio	Toledo	Ohio
United States	NNS Clinical Research LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain amyloid load as assessed by amyloid PET imaging		Baseline to Week 69
Secondary	Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease		Baseline to Week 69
Secondary	Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging		Baseline to Week 69
Secondary	Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score		Baseline to Week 73