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Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB076 in Healthy Volunteers and Subjects With Alzheimer's Disease

NCT03056729•Biogen

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076 after single-dose administration. Another secondary objective is to evaluate the immunogenicity of BIIB076 in serum after single-dose administration.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
•Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD according to the National Institutes of Aging-Alzheimer's Association \[McKhann 2011\], and in addition must have the following:
•Clinical Dementia Rating (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD.
•CDR Memory Box Score of ≥0.5.
•Mini-Mental State Examination score between 18 and 30 (inclusive) at Screening.
•Must have amyloid beta positivity confirmed at Screening

Exclusion Criteria

•Brain MRI findings that 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).
•Any medical or neurologic/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment (e.g.,current history of substance abuse, uncontrolled vitamin B12 deficiency or uncontrolled thyroid disease, stroke or other cerebrovascular condition, Parkinson's disease, Lewy body dementia, or frontotemporal dementia or head trauma), or could lead to discontinuation, noncompliance with study assessments, or safety concerns.
•Diagnosis within 1 year prior to Screening and/or evidence of clinically significant (in the opinion of the Investigator) psychiatric illness including uncontrolled major depression, bipolar affective disorder, other psychiatric illness, and suicidal ideation.
•Any documented prior history of chronic schizophrenia.
•History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including chronic obstructive pulmonary disease), neurologic, dermatologic, or renal disease, or other major disease, as determined by the Investigator.
•Use of any medications for the treatment of comorbid conditions that have not been stable for at least 8 weeks prior to Day -1 and/or that are not expected to remain stable for the duration of the study.
+8 more criteria

Locations (8)

MD Clinical

Hallandale, Florida, United States

Bioclinica Research

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Indiana University

Indianapolis, Indiana, United States

St Louis Clinical Trial

St Louis, Missouri, United States

Covance Dallas CRU

Dallas, Texas, United States

Covance CRU

Madison, Wisconsin, United States

Key Dates

Start Date

February 17, 2017

Primary Completion Date

March 3, 2020

Completion Date

March 3, 2020

Last Updated

March 24, 2020

Enrollment

ACTUAL participants

Conditions

Alzheimer's DiseaseHealthy Volunteer

Interventions

BIIB076

DRUG

Placebo

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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