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

Recruiting

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.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All No
May 16, 2019
November 15, 2020
33

  • 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

  • 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

ORY-2001 is a drug being investigated for its potential to slow cognitive impairment and improve memory in people with Alzheimer's disease. Participants will be randomly assigned to take either the study drug or a placebo for 4 months, with a 4-month extension during which all participants will be assigned to one of two doses of the study drug.

Name City State Zip Status Primary Contact
Alzheimer's Research and Treatment Center
Lake Worth Florida 33449 Recruiting David Watson, Psy. D
561-209-2400
Columbus Memory Center
Columbus Georgia 31909 Recruiting Dawn Pitman
706-324-2557
research5@lissmd.com
Princeton Medical Institute
Princeton New Jersey 08540 Recruiting Olga Tchikindas, MD

Abington Neurological Associates Ltd.
Willow Grove Pennsylvania 191090 Recruiting David Weisman, Dr
215-957-9250
dcweisman@gmail.com

Oryzon Genomics S.A.

  • Alzheimer’s Drug Discovery Foundation

Name Role Affiliation
Michael Ropacki, MD Study Director Oryzon Genomics S.A.

Name Phone Email
Jessica Goldenberg, M.S. 609-921-6868 J.Goldenberg@gctrials.com

NCT03867253

A Multicentre, Randomised, Double-blind, Placebo-controlled, 3-arm, 24-week Parallel-group Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ORY-2001 in Patients With Mild-moderate Alzheimer's Disease