Multiple Dose Study of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease.

This study is currently recruiting participants.
Verified April 2013 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01677572
First received: August 30, 2012
Last updated: September 12, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate the safety and tolerability of multiple doses of BIIB037 administered via intravenous (IV) infusions in subjects with prodromal or mild Alzheimer's Disease (AD). Patients who meet the inclusion criteria will be eligible for a dose-blinded long-term extension (LTE), following the double-blinded placebo-controlled portion, with all subjects receiving BIIB037.


Condition Intervention Phase
Alzheimer's Disease
Drug: BIIB037
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Safety and tolerability as measured by adverse event monitoring and brain magnetic resonance imaging findings including the incidence of amyloid-related imaging abnormality-edema and amyloid-related imaging abnormality-hemorrhage. [ Time Frame: Baseline to week 126 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline as measured by 18F-AV-45 PET scan [ Time Frame: at week 26 and week 54 ] [ Designated as safety issue: Yes ]
  • Multiple dose pharmacokinetic (PK) serum concentrations of BIIB037 [ Time Frame: up to week 52 ] [ Designated as safety issue: Yes ]
  • Immunogenecity of BIIB037 after multiple dose administration [ Time Frame: Baseline to week 70 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB037
Administered by intravenous (IV) infusion
Drug: BIIB037
Subjects will recevie multiple doses of BIIB037 intravenous (IV) infusion
Placebo Comparator: Placebo
Administered by intravenous (IV) infusion
Drug: Placebo
intravenous (IV) infusion

Detailed Description:

BIIB037 is an investigational product being developed as a disease modification treatment for Alzheimer's disease (AD). BIIB037 is a fully human monoclonal antibody that recognizes amyloid plaques. In animal models of Alzheimer's disease, treatment with BIIB037 was shown to decrease beta amyloid content in animal brain. A single ascending dose study of BIIB037 in subjects with mild to moderate Alzheimer's Disease (AD) is ongoing. This study will be conducted in subjects with prodromal or mild Alzheimer's Disease (AD) to assess the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile after multiple doses of BIIB037.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must meet criteria for Prodromal Alzheimer's Disease (AD) or Mild Alzheimer's Disease (AD):

    1. Mini Mental State Examination (MMSE) score between 20-30,
    2. Clinical Dementia Rating Scale (CDR) score of 0.5 or 1.0, and
    3. a free recall score of lesser or equal to 27 on the Free and Cued Selective Reminding Test (FCSRT) for prodromal Alzheimer's Disease (AD).
  • Subjects must have a positive florbetapir positron emission tomography (PET) amyloid scan.
  • Subjects must consent to apolipoprotein E (APOE) genotyping.
  • Apart from clinical diagnosis of Alzheimer's Disease (AD), subject must be in good health.
  • Must have a reliable informant or caregiver.

Inclusion Criteria for the Long Term Extension (LTE), candidates must meet the following eligibility criteria at Week 56:

  1. Subject must have completed the placebo-controlled portion of the study. Subject must have received 11 or more doses, and must not have missed more than 2 consecutive doses; subjects who don't meet this criteria can only enter the Long Term Extension (LTE) upon Sponsor's approval.
  2. Mini Mental State Examination (MMSE) score >10 at the Week 54 visit.
  3. Subject (or subject's legal representative) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or assent) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  4. Must be ambulatory.

Exclusion Criteria:

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment.
  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year.
  • Clinically significant psychatric illness in past 6 months.
  • Seizure in the past 3 years.
  • Poorly controlled diabetes mellitus.
  • History of unstable angina, myocardial infarction, chronic heart failure, or clinical significant conduction abnormalities within 1 year prior to Screening.
  • Indication of impaired renal or liver function.
  • Have human immunodeficiency virus (HIV) infection.
  • Have a significant systematic illness or infection in past 30 days.
  • Brain MRI showing evidence of acute or sub-acute micro or macrohemorrhage, greater than 4 microhemorrhages, cortical infarct or greater than one 1 lunar infarct.
  • Any contraindications to brain MRI or positron emission tomography (PET) scans.
  • Negative positron emission tomography (PET) scan with any amyloid-targeting ligand within 48 weeks of Screening.
  • Clinically significant 12-lead electrocardiogram (ECG) abnormalities.
  • Alcohol or substance abuse in past 1 year.
  • Taking blood thinners (except for aspirin at a prophylactic dose or less)
  • Have changes in medications or doses of medication in past 4 weeks.

Exclusion Criteria for Long-term Extension:

Any medical or psychiatric contraindication or clinically significant abnormality that, in opinion of the Investigator, will substantially increase the risk associated with the subject's participation in and completion of the study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677572

Contacts
Contact: Medical Director 221AD103@biogenidec.com

Locations
United States, Arizona
Research Site Recruiting
Tucson, Arizona, United States
United States, California
Research Site Recruiting
San Francisco, California, United States
United States, Florida
Research Site Recruiting
Delray Beach, Florida, United States
Research Site Recruiting
Fort Myers, Florida, United States
Research Site Recruiting
Hallendale Beach, Florida, United States
Research Site Recruiting
Orlando, Florida, United States
Research Site Recruiting
Tampa, Florida, United States
United States, Missouri
Research Site Recruiting
St. Louis, Missouri, United States
United States, New Jersey
Research Site Recruiting
Eatontown, New Jersey, United States
Research Site Recruiting
Toms River, New Jersey, United States
United States, Ohio
Research Site Recruiting
Beechwood, Ohio, United States
Research Site Recruiting
Toledo, Ohio, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01677572     History of Changes
Other Study ID Numbers: 221AD103, EUDRA CT #: 2012-000349-10
Study First Received: August 30, 2012
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014