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Find more clinical trials

BIIB092 in Primary Tauopathies

Start: September 12, 2018
End: December 2019
Enrollment: 32

What Is This Study About?

This Phase 1b randomized clinical trial will test the safety, tolerability, and effects of the investigational drug BIIB092, a monoclonal antibody, when it is intravenously infused in people that have one of four different tauopathy syndromes.

Do I Qualify To Participate in This Study?

Minimum Age: 35 Years

Maximum Age: 80 Years

Must have:

All study participants:

  • Able to walk at least 10 steps with minimal assistance (stabilization of one arm or use of cane/walker)
  • No large strokes or severe white matter disease
  • Mini-Mental State Examination of 20 to 30
  • Amyloid beta positron emission tomography (PET) scan not consistent with underlying Alzheimer's disease
  • If on the following medications, stable for 2 months prior to screening:
    • FDA-approved Alzheimer's medications
    • FDA-approved Parkinson's disease medications
      (Other medications, except those listed under exclusion criteria, are allowed as long as the dose is stable for 30 days prior to screening)
  • Study partner who agrees to accompany the participant to visits and spends at least 5 hours per week with the participant
  • Agrees to 3 lumbar punctures
  • Women of childbearing potential must agree to abstain from sex or use an adequate method of contraception through the screening and study periods and for 155 days after the last dose of study drug
  • Males must agree to abstain from sex with women of childbearing potential or use an adequate method of contraception for the duration of the study period and for 215 days after the last dose of study drug

Participants with Amyloid PET (-) corticobasal syndrome (CBS):

  • MRI consistent with CBS
  • Meets criteria for possible or probable corticobasal degeneration (CBD), CBS subtype

Participants with nonfluent variant primary progressive aphasia (nfvPPA):

  • MRI consistent with nfvPPA
  • Meets criteria for nfvPPA

Participants with autosomal dominant genetic forms of frontotemporal lobar degeneration (FTD) due to the presence of a mutation in the microtubule-associated protein tau gene (sMAPT):

  • MRI consistent with sMAPT diagnosis
  • Has known frontotemporal lobar degeneration- (FTLD-) causative MAPT mutation
  • CDR-FTLD sum of boxes score 1.0
  • Has any clinical phenotype of sMAPT

Participants with traumatic encephalopathy syndromes (TES):

  • MRI consistent with TES diagnosis
  • Meets criteria for probable TES
  • At least 5 years or greater between symptom onset and first known traumatic brain injury/concussive episode

Must NOT have:

  • Diagnosis of probable Alzheimer's or progressive supranuclear palsy- Richardson's syndrome (PSP-RS) (diagnosis of progressive supranuclear palsy [PSP] or progressive supranuclear palsy-corticobasal syndrome [PSP- CBS] would not be exclusionary)
  • Any other medical condition other than CBS, nfvPPA, sMAPT, or TES that could account for cognitive or motor deficits (e.g., active seizure disorder, stroke, vascular dementia, substance abuse or alcoholism)
  • History of a prominent and sustained response to levodopa therapy
  • History of significant cardiovascular, hematologic, renal, or hepatic disease
  • History of major psychiatric illness or untreated depression
  • Neutrophil count of less than 1,500/mm3, platelets less than 100,000/mm3, serum creatinine greater than 1.5 times the upper limit of normal (ULN), total bilirubin greater than 1.5 times the ULN, alanine aminotransferase (ALT) greater than 3 times the ULN, aspartate aminotransferase (AST) greater than 3 times ULN, or International Normalized Ratio (INR)  greater than 1.2
  • Current or recent history of a clinically significant bacterial, fungal, or mycobacterial infection
  • Current clinically significant viral infection
  • Major surgery within the past four weeks
  • Any contraindication for magnetic resonance imaging (MRI) or inability to tolerate MRI scan
  • Any contraindication to or inability to tolerate lumbar puncture, including use of anti-coagulant medications such as warfarin
  • Prior treatment with BIIB092
  • Treatment with another investigational drug within 30 days or 5 half-lives of the drug, whichever is longer
  • Treatment with systemic corticosteroids within 30 days or 5 half-lives of the drug, whichever is longer
  • Known hypersensitivity to the inactive ingredients in the study drug (BIIB092 or placebo)
  • Known to be pregnant or lactating or positive pregnancy test
  • Cancer within 5 years (except for basal cell carcinoma)
  • History of serum or plasma progranulin level less than one standard deviation below the normal participant mean for the laboratory performing the assay
  • History or evidence of known disease-associated mutations in GRN, TBK1, C9ORF72, TARBP, CHMPB2, or VCP genes (frontotemporal lobar degeneration causative gene mutations not associated with underlying tau pathology)

If I Qualify, Who Do I Contact?

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

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: University of California, San Francisco

Source: ClinicalTrials.gov ID: NCT03658135

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