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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01397578
Collaborator
(none)
91
Enrollment
29
Locations
4
Arms
32
Actual Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 31, 2011
Actual Primary Completion Date :
Apr 30, 2014
Actual Study Completion Date :
Apr 30, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Subcutaneous cohort exp

Drug: MABT5102A
Repeating subcutaneous injection
Experimental: Part 2: Intravenous cohort exp

Drug: MABT5102A
Repeating intravenous infusion
Placebo Comparator: Part 1: Subcutaneous cohort

Repeating subcutaneous injection

Drug: placebo
Repeating subcutaneous injection
Placebo Comparator: Part 2: Intravenous cohort

Repeating intravenous injection

Drug: placebo
Repeating intravenous infusion

Outcome Measures

Primary Outcome Measures

  1. Change in brain amyloid load as assessed by amyloid PET imaging [Baseline to Week 69]

Secondary Outcome Measures

  1. Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease [Baseline to Week 69]

  2. Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging [Baseline to Week 69]

  3. Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score [Baseline to Week 73]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner Alzheimer's Institute Phoenix Arizona United States 85020
2 Banner Sun Health Research Insitute Sun City Arizona United States 85351
3 NNS Clinical Research LLC Tucson Arizona United States 85704
4 Margolin Brain Institute Fresno California United States 93720
5 University of California Los Angeles (UCLA) Los Angeles California United States 90095
6 Pacific Neuroscience Med Grp Oxnard California United States 93030
7 Stanford Univ Medical Center Palo Alto California United States 94304
8 Redwood Regional Medical Group Santa Rosa California United States 95403
9 Internal Med Assoc of Lee Cty Fort Myers Florida United States 33912
10 Neuropsychiatric Research; Center of Southwest Florida Fort Myers Florida United States 33912
11 MD Clinical Hallandale Beach Florida United States 33009
12 Compass Research Orlando Florida United States 32806
13 Dekalb Neurology Associates Decatur Georgia United States 30033
14 Alexian Brothers Neurosci Inst Elk Grove Village Illinois United States 60007
15 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
16 Cleveland Clinic Lou Ruvo; Center for Brain Research Las Vegas Nevada United States 89106
17 Memory Enhancement Center of America, Inc. Eatontown New Jersey United States 07724
18 Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch. Manhasset New York United States 11030
19 Neurology & Neuroscience Ctr of Ohio Toledo Ohio United States 43623
20 The Clinical Trial Center, LLC Jenkintown Pennsylvania United States 19046
21 Rhode Island Mood & Memory Research Institute East Providence Rhode Island United States 02914
22 Butler Hospital Providence Rhode Island United States 02906
23 Hopital Central-CHU de Nancy; Pharmacie Nancy France 54035
24 Hôpital Casselardit; Cons memoire Toulouse France 31059
25 Clinique Psychiatrique Univ Tours Cedex 9 France 37044
26 Fundació ACE BArcelon Barcelona Spain 08034
27 Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
28 Hospital del Mar Barcelona Spain 08003
29 Hospital Mutua De Terrasa Barcelona Spain 08221

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Robert Paul, M.D., Ph.D., Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01397578
Other Study ID Numbers:
  • ABE4955g
  • GN00762
First Posted:
Jul 19, 2011
Last Update Posted:
Jul 12, 2017
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:
Alzheimer Disease
Antibodies, Monoclonal

Study Results

No Results Posted as of Jul 12, 2017