A Long-Term Safety Extension Study of Studies ABE4869g And ABE4955g in Patients With Mild To Moderate Alzheimer's Disease Treated With Crenezumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01723826
First received: November 6, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This Phase II, open-label extension (OLE), multicenter study will evaluate the l ong-term safety and tolerability of crenezumab in patients with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g or ABE4955g. Patients will receive crenezumab at the same dosing frequency, dose level and route of administration they were ass igned to after the Week 73 visit of Study ABE4869g or ABE4955g. Patients who rec eived placebo in Study ABE4869g or ABE4955g will receive active drug. Anticipate d time on study treatment is 94 weeks.


Condition Intervention Phase
Alzheimer Disease
Drug: crenezumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Long-Term Safety Extension Of Phase II Studies ABE4869g And ABE4955g In Patients With Mild To Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Frequency of adverse events during the treatment period [ Time Frame: 105 weeks ] [ Designated as safety issue: No ]
  • Nature and severity of adverse events during the treatment period [ Time Frame: 105 weeks ] [ Designated as safety issue: No ]
  • Changes in vital signs/physical findings [ Time Frame: from baseline to Week 105 ] [ Designated as safety issue: No ]
  • Changes in neurological findings [ Time Frame: from baseline to Week 105 ] [ Designated as safety issue: No ]
  • Changes in laboratory test results [ Time Frame: from baseline to Week 105 ] [ Designated as safety issue: No ]
  • Incidence of human anti-therapeutic antibody (ATA) formation [ Time Frame: 105 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of ARIA-E and amyloid-related imaging abnormalities-hemorrhage (ARIA-H) [ Time Frame: 105 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 360
Study Start Date: December 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crenezumab Drug: crenezumab
dosing frequency, dose level and route of administration as assigned to after the Week 73 visit of study ABE4869g or ABE4955g

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73 visit
  • Adequate visual and auditory acuity, in the investigator's judgment, to allow for neuropsychological testing
  • Availability of a person ("caregiver") who can provide information on activities of daily living and behavior in order to complete the study-specific assessments
  • Diagnosis of probable Alzheimer's disease according to the National Institute on Neurological and Communication Disease and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)
  • MMSE score of 12 or more at screening (Folstein et al. 1975)
  • For male patients with partners with reproductive potential, agreement to use a reliable means of contraception (e.g., condoms) during the study
  • For female patients, a negative pregnancy test at screening
  • Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73 visit
  • Diagnosis of probable Alzheimer's disease according to the National Institute on Neurological and Communication Disease and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)
  • MMSE score of 12 or more at screening (Folstein et al. 1975)

Exclusion Criteria:

  • Early treatment and/or study discontinuation prior to completion of the Week 73 visit of Genentech Study ABE4869g or ABE4955g
  • Inability to tolerate MRI procedures or contraindication to MRI
  • Female patient with reproductive potential: Female patients must either have undergone documented surgical sterilization or have not experienced menstruation for at least 12 consecutive months
  • 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
  • History of severe, clinically significant central nervous system trauma
  • History or presence of clinically relevant intracranial tumor
  • Presence of infections that affect the brain function or history of infections that resulted in neurologic sequelae
  • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease
  • History or presence of a neurologic disease other than Alzheimer's disease that may affect cognition
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
  • Evidence of malignancies (except squamous cell cancer or basal cell cancer of the skin), acute infections, renal failure that requires dialysis, or other unstable medical disease not related to Alzheimer's disease that, in the investigator's opinion, would preclude patient participation. Cancer that is not being actively treated with anti-cancer therapy or radiotherapy as well as cancers that are considered to have low probability of recurrence are allowed
  • History or presence of atrial fibrillation that, in the investigator's judgment, poses a risk for future stroke
  • Chronic kidney disease of Stage >/= 4, according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines for chronic kidney disease (CKD)
  • Impaired hepatic function
  • Presence of superficial siderosis of central nervous system, more than eight cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage
  • Presence of any other significant cerebral abnormalities, including ARIA-E
  • Treatment with anticoagulation medications within 75 weeks prior to enrollment Clopidogrel, dipyridamole, and aspirin are permitted
  • Treatment with anticholinergic antidepressants, typical antipsychotics, barbiturates, or narcotics within 5 half-lives or 3 months prior to screening, whichever is longer
  • All other antidepressants and atypical antipsychotics are allowed. Chronic use of benzodiazepines is not allowed; however, the intermittent use of benzodiazepines is allowed, except within 2 days prior to any neurocognitive assessment
  • Early treatment and/or study discontinuation prior to completion of the Week 73 visit of Genentech Study ABE4869g or ABE4955g
  • 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
  • History of severe, clinically significant central nervous system trauma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723826

  Show 86 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01723826     History of Changes
Other Study ID Numbers: GN28525, 2012-003242-33
Study First Received: November 6, 2012
Last Updated: October 6, 2014
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 October 19, 2014