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BIIB076 for Early Alzheimer's Disease

Start: February 17, 2017
End: March 3, 2020
Enrollment: 56

What Is This Study About?

This study will evaluate the safety and tolerability of BIIB076 in cognitively normal older adults and older adults with Alzheimer's disease.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 80 Years

Must have:

Cognitively Normal Participants

  • In good health based on medical history and screening evaluations

Participants with Alzheimer's Disease

  • Diagnosis of mild Alzheimer's disease
  • Concentrations of amyloid-beta and tau in cerebrospinal fluid consistent with diagnosis of Alzheimer's
  • Mini-Mental State Exam score of 20-26 (inclusive)

Must NOT have:

Cognitively Normal Participants

  • Evidence on magnetic resonance image of acute or subacute hemorrhage, prior macrohemorrhage, stroke, or history of diffuse white-matter disease
  • History of clinically significant heart, endocrine, gastrointestinal, blood, liver, immune system, metabolic, urologic, lung, neurologic, skin, kidney, or other major disease or psychiatric disorder
  • Enrollment in another study with an investigational drug or therapy within 30 days (6 months for biologics) or 5 half-lives, whichever is longer
  • Inability to undergo magnetic resonance imaging or lumbar puncture due to pacemaker, incompatible aneurysm clips, artificial heart valves, other metal foreign body, claustrophobia, or other reason

Participants with Alzheimer's Disease

  • Any medical or neurologic/neurodegenerative condition (other than Alzheimer's) that could affect cognitive impairment, including substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, frontotemporal dementia, and head trauma
  • Clinically significant psychiatric illness, including uncontrolled major depression, schizophrenia, or bipolar disorder within the past 6 months
  • History of clinically significant heart, endocrine, gastrointestinal, blood, liver, immune system, metabolic, urologic, lung, neurologic, skin, kidney, or other major disease
  • Enrollment in another study with an investigational drug or therapy within 30 days (6 months for biologics) or 5 half-lives, whichever is longer
  • Inability to undergo magnetic resonance imaging or lumbar puncture, due to pacemaker, incompatible aneurysm clips, artificial heart valves, other metal foreign body, claustrophobia, or other reason
  • History of or ongoing chronic uncontrolled hypertension
  • History of unstable angina, heart attack, chronic heart failure, or significant conduction abnormalities, such as unstable atrial fibrillation, within past year

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

For information on this trial or study sites, please contact 866-633-4636 or clinicaltrials@biogen.com.

 

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Biogen

Source: ClinicalTrials.gov ID: NCT03056729