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?
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?
Lead: Oryzon Genomics S.A.
Collaborator Sponsor
-
Alzheimer’s Drug Discovery Foundation
Source: ClinicalTrials.gov ID: NCT03867253