A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:2/24/2019
Start Date:December 7, 2012
End Date:February 8, 2017

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A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term
safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's
disease who have participated in and completed the treatment period of the Phase II Study
ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study
ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on
study treatment is 144 weeks.


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)

- Mini-Mental State Examination (MMSE) score of 10 or more at screening (Folstein et al.
1975)

- For male participants with partners with reproductive potential, agreement to use a
reliable means of contraception (e.g., condoms) during the study and for at least 8
weeks following the last dose of study drug

- For female participants, a negative pregnancy test at screening

Exclusion Criteria:

- Early treatment and/or study discontinuation prior to completion of the Week 73 visit
of Genentech Study ABE4869g or ABE4955g

- Early discontinuation from the treatment schedule of a prior version of Study GN28525
for safety reasons. If treatment discontinuation occurred for safety reasons,
participants may not re-start dosing on extended treatment schedules offered in
amendments to Study GN28525

- Inability to tolerate Magnetic Resonance Imaging (MRI) procedures or contraindication
to MRI

- Female participants with reproductive potential: Female participants 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 participant'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 participant's participation. Cancer that is not being actively
treated with anti-cancer therapy or radiotherapy as well as cancers which 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 greater than or equal to (>=) 4, according to the
National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI)
guidelines for chronic kidney disease (CKD)

- Impaired hepatic function

- Impaired coagulation (activated partial thromboplastin time [aPTT] greater than [>]
1.2 times upper limit of normal [ULN])

- Platelet count less than (<) 100,000 per microliter (mcL)

- Presence at screening of superficial siderosis of central nervous system, more than 8
cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage

- Presence at screening of any other significant cerebral abnormalities, including
ARIA-E

- Treatment with anticoagulation medications within 2 weeks prior to enrollment.
Clopidogrel, dipyridamole, and aspirin are permitted

- Treatment with anticholinergic antidepressants, typical antipsychotics, or
barbiturates within 2 weeks prior to enrollment. All other antidepressants and
atypical antipsychotics are allowed with certain restrictions as defined in the
protocol

- Chronic use of opiates, opioids, or benzodiazepines

- Any biologic therapy within 75 weeks prior to enrollment

- Any investigational agent (other than crenezumab) within 75 weeks prior to enrollment

- 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
We found this trial at
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Tampa, Florida 33609
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777 Glades Road
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Decatur, Georgia 30033
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Delray Beach, Florida 33445
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East Providence, Rhode Island 02914
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Eatontown, New Jersey 07724
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800 Biesterfield Road
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6345 Balboa Boulevard
Encino, California 91316
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Fresno, California 93720
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Hattiesburg, Mississippi 39401
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340 West 10th Street
Indianapolis, Indiana 46202
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Jenkintown, Pennsylvania 19046
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360-1855 Kirschner Road
Kelowna, British Columbia V1Y 4N7
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9444 Medical Center Drive
La Jolla, California 92037
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
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Latham, New York 12110
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1975 Zonal Avenue
Los Angeles, California 90033
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Los Angeles, California 90095
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350 Community Drive
Manhasset, New York 11030
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5200 Northeast 2nd Avenue
Miami, Florida 33137
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Mount Arlington, New Jersey 07856
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Naples, Florida 34102
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New Haven, Connecticut 6520
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Orleans, Louisiana 70114
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630 W 168th St
New York, New York
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1601 Dove Street
Newport Beach, California 92660
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171 Ashley Avenue
North Charleston, South Carolina 29425
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100 West Gore Street
Orlando, Florida 32806
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Oxnard, California 93030
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345 Blackstone Blvd
Providence, Rhode Island 02906
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Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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Raleigh, North Carolina 27607
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435 East Henrietta Road
Rochester, New York 14627
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601 Elmwood Avenue
Rochester, New York 14642
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Sacramento, California 95817
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