Clinical trial NCT01397578: A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 91
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in brain amyloid load as assessed by amyloid PET imaging
timeFrame: Baseline to Week 69
Secondary outcomes:
measure: Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease
timeFrame: Baseline to Week 69
measure: Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging
timeFrame: Baseline to Week 69
measure: Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score
timeFrame: Baseline to Week 73
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Insitute
state: Arizona
city: Tucson
country: United States
facility: NNS Clinical Research LLC
state: Arizona
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Med Grp
state: California
city: Palo Alto
country: United States
facility: Stanford Univ Medical Center
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group
state: California
city: Fort Myers
country: United States
facility: Internal Med Assoc of Lee Cty
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research; Center of Southwest Florida
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Decatur
country: United States
facility: Dekalb Neurology Associates
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosci Inst
state: Illinois
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo; Center for Brain Research
state: Nevada
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Manhasset
country: United States
facility: Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
state: New York
city: Toledo
country: United States
facility: Neurology & Neuroscience Ctr of Ohio
state: Ohio
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Nancy
country: France
facility: Hopital Central-CHU de Nancy; Pharmacie
city: Toulouse
country: France
facility: Hôpital Casselardit; Cons memoire
city: Tours Cedex 9
country: France
facility: Clinique Psychiatrique Univ
city: BArcelon
country: Spain
facility: Fundació ACE
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Mutua De Terrasa
Study officials:
affiliation: Genentech, Inc.
name: Robert Paul, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.
citation: Salloway S, Honigberg LA, Cho W, Ward M, Friesenhahn M, Brunstein F, Quartino A, Clayton D, Mortensen D, Bittner T, Ho C, Rabe C, Schauer SP, Wildsmith KR, Fuji RN, Suliman S, Reiman EM, Chen K, Paul R. Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer's disease (BLAZE). Alzheimers Res Ther. 2018 Sep 19;10(1):96. doi: 10.1186/s13195-018-0424-5.