Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02353598 : A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease
PhasePhase 1
AgesMin: 50 Years Max: 90 Years
Eligibility
Inclusion Criteria:

- Body weight greater than or equal (>/=) 45 kilograms (kg) and less than or equal
(
- Ages 50-90 years, inclusive

- Availability of a person ("caregiver") who, in the investigator's judgment, has
frequent and sufficient contact with the participant and is able to provide accurate
information regarding the participant's cognitive and functional abilities, agrees to
provide information at clinic visits, which require partner input for scale
completion, and signs the necessary consent form

- Willingness and ability to complete all aspects of the study; the participant should
be capable of completing assessments either alone or with the help of the caregiver

- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to
perform the neuropsychological testing

- Clinical diagnosis of probable mild to moderate AD based on the national institute on
neurological and communication disease and stroke/Alzheimer's disease and related
disorders association (NINCDS/ADRDA) criteria or probable major neurocognitive
disorder due to AD of mild to moderate severity based on diagnostic and statistical
manual of mental disorders, version 5 (DSM-5) criteria

- Screening MMSE score of 18-28 points, inclusive

- Screening clinical dementia rating global score (CDR-GS) of 0.5 or 1.0

- Screening geriatric depression (GDS)-15 score less than (<) 6

- Positive florbetapir amyloid positron emission tomography (PET) scan by qualitative
read conducted by the core/central PET laboratory

- Women must be postmenopausal or surgically sterile

- Men with female partners of childbearing potential agree to remain abstinent or use
adequate methods of contraception as defined by protocol during the treatment period
and for at least 8 weeks after the last dose of study drug and agreement to refrain
from donating sperm during this same period

Exclusion Criteria:

- History or presence of clinically evident vascular disease potentially affecting the
brain that, in the opinion of the investigator, has the potential to affect cognitive
function

- History or presence of stroke within the previous 2 years or documented history of
transient ischemic attack within the previous 12 months

- History of severe, clinically significant central nervous system trauma

- History or presence of intracranial tumor that is clinically relevant in the opinion
of the investigator

- Presence of infections that affect brain function or history of infections that
resulted in neurologic sequelae

- History or presence of systemic autoimmune disorders potentially causing progressive
neurologic disease with associated cognitive deficits

- History or presence of a neurologic disease other than AD that may affect cognition

- Presence of superficial siderosis, more than four cerebral microhemorrhages, or
evidence of a prior cerebral macrohemorrhage

- Inability to tolerate magnetic resonance imaging (MRI) procedures or contraindication
to MRI

- History or presence of atrial fibrillation except if only one episode that resolved
more than 1 year ago and for which treatment is no longer indicated or that in the
investigator's judgment poses no risk for future stroke

- Within the previous 2 years, unstable or clinically significant cardiovascular
disease

- Uncontrolled hypertension

- Chronic kidney disease of Stage >/= 4, according to the national kidney foundation
kidney disease outcomes quality initiative (NKF KDOQI) guidelines for chronic kidney
disease

- Impaired hepatic function

- Clinically significantly abnormal screening blood or urine that remain abnormal on
retest

- History of malignancies within 5 years prior to screening, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I
uterine cancer; cancer that is considered likely to be cured, is not being actively
treated with anti-cancer therapy or radiotherapy and not likely to require treatment
in the ensuing 5 years as well as cancers that are considered to have low probability
of recurrence are allowed

- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions
to chimeric, human, or humanized antibodies or fusion proteins

- Severe or unstable medical condition that, in the opinion of the investigator or
sponsor, could be expected to progress, recur, or change to such an extent that it
could put the patient at special risk, bias the assessment of the clinical or mental
status of the patient to a significant degree, interfere with the patient's ability
to complete the study assessments, or would require the equivalent of institutional
or hospital care

- Any previous treatment with medications used to treat Parkinsonian symptoms or any
other neurodegenerative disorder within 1 year before screening even if the patient
is taking the medicine for a non-neurodegenerative disorder such as restless leg
disorder

- Typical anti-psychotic or neuroleptic medication within 6 months before screening
except as brief treatment for a non-psychiatric indication

- Antihemostasis medication within 2 weeks before screening

- Sedative, hypnotic, or benzodiazepine medication within 3 months before screening
except intermittent use of the following for sleep or anxiety: alprazolam, lorazepam,
oxazepam, temazepam, diazepam, or a short-acting benzodiazepine-like medication
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02353598      |      Link to official Clinicaltrials.gov listing
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