Clinical Trial Details
Braintumor Website

[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.]

NCT03056729 : Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease
PhasePhase 1
AgesMin: 50 Years Max: 75 Years
Eligibility
Key Inclusion Criteria - Healthy Participants

- Must be in good health as determined by the Investigator, based on medical history
and Screening evaluations.

Key Inclusion Criteria - Participants with Alzheimer's Disease (AD)

- Must have a clinical diagnosis of mild AD consistent with the following:

- Probable AD, according to the National Institute on Aging - Alzheimer's Association
workgroups on diagnostic guidelines for AD criteria [McKhann 2011].

- CSF concentrations of A?42 and t-tau consistent with diagnosis of AD.

- Must have a Mini-Mental State Examination score between 20 and 26 (inclusive) at
Screening.

Key Exclusion Criteria - Healthy Participants

- Brain MRI performed at Screening that shows showing evidence of acute or sub-acute
hemorrhage, prior macrohemorrhage, cortical infract, >1 lacunar infarct, history of
diffuse white-matter disease or any finding that, in the opinion of the Investigator,
might be a contributing cause of the participant's dementia, might pose a risk to the
participant, or might prevent a satisfactory MRI assessment for safety monitoring.

- History of any clinically significant cardiac, endocrine, gastrointestinal,
hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,
dermatologic, psychiatric, or renal disease, or other major disease, as determined by
the Investigator.

- Current enrollment in any other drug, biologic, device, or clinical study or
treatment with an investigational drug or approved therapy for investigational use
within 30 days (6 months for biologics) or 5 half-lives, whichever is longer, prior
to Day-1.

- Contraindications to having a brain MRI (e.g., pacemaker; MRI-incompatible aneurysm
clips, artificial heart valves, or other metal foreign body; claustrophobia that
cannot be medically managed).

- Contraindications to having an Lumbar Puncture (LP).

Key Exclusion Criteria - Participants with Alzheimer's Disease (AD)

- Any medical or neurologic/neurodegenerative condition (other than AD) that, in the
opinion of the Investigator, might be a contributing cause of the participant's
cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid
function, stroke or other cerebrovascular condition, Lewy body dementia, front
temporal dementia, head trauma).

- Clinically significant psychiatric illness (e.g., uncontrolled major depression,
schizophrenia, bipolar affective disorder) within 6 months prior to Screening.

- History of any clinically significant cardiac, endocrine, gastrointestinal,
hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,
dermatologic, or renal disease, or other major disease, as determined by the
Investigator.

- Current enrollment in any other drug, biologic, device, or clinical study or
treatment with an investigational drug or approved therapy for investigational use
within 30 days (6 months for biologics) or 5 half-lives, whichever is longer, prior
to Day-1.

- Contraindications to having a brain MRI (e.g., pacemaker; MRI-incompatible aneurysm
clips, artificial heart valves, or other metal foreign body; claustrophobia that
cannot be medically managed).

- Contraindications to having an LP.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03056729      |      Link to official Clinicaltrials.gov listing
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