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ORY-2001 for Mild to Moderate Alzheimer's Disease (ETHERAL-US)

Start: May 16, 2019
End: November 12, 2020
Enrollment: 33

What Is This Study About?

This Phase IIa study will assess the safety, tolerability, and preliminary efficacy of the experimental drug ORY-2001 in adults with mild to moderate Alzheimer's disease.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 85 Years

Must have:

  • Diagnosis of probable Alzheimer's disease
  • Mini-Mental State Examination score of 16 to 26
  • Evidence of Alzheimer's disease changes in the brain, as indicated by levels of the proteins amyloid-beta and tau in cerebrospinal fluid
  • Outpatient consulting with a general practitioner or a psychiatrist/neurologist/geriatrician
  • Knowledgeable and reliable close relative/caregiver who can come to study visits
  • Use of acetylcholinesterase inhibitor must be on stable dose
  • If fertile, must use highly effective contraception from screening until 90 days after last dose

Must NOT have:

  • Hospitalization or change of medications 1 month prior to screening or during screening period
  • Clinical, laboratory, or neuroimaging findings of another primary degenerative dementia, other neurodegenerative condition, cerebrovascular disease, or other central nervous system disease
  • Current diagnosis of major depression, schizophrenia, or bipolar disorder
  • Positive results for tuberculosis, HIV, hepatitis C, or hepatitis B
  • Significant, advanced, or unstable disease that may interfere with evaluation
  • Disability that may prevent completion of study requirements
  • Treatment with amyloid-beta or tau antibodies or other disease-modifying strategies within 3 months or 5 half-lives, whichever is longer, prior to screening
  • Treatment with an active vaccine targeting amyloid-beta or tau proteins
  • Suspected or known drug or alcohol abuse
  • Metal implants or other condition that would prevent brain magnetic resonance imaging
  • Enrollment in another investigational study or intake of investigational drug within past 3 months
  • Suicide attempt within last year or significant risk of suicide

If I Qualify, Who Do I Contact?

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

 
Study Contact
Jessica Goldenberg, M.S.

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: Oryzon Genomics S.A.

Collaborator Sponsor

  • Alzheimer’s Drug Discovery Foundation

Source: ClinicalTrials.gov ID: NCT03867253