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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.

 

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