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

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?

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.

 

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