Testing the Safety and Preliminary Efficacy of the New Drug ORY-2001 in Mild to Moderate Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild to Moderate Alzheimer's Disease

In brief

This is a Phase IIa study assessing the safety, tolerability and preliminary efficacy of ORY-2001 in mild to moderate Alzheimer's Disease patients.

Key facts

Study ID: NCT03867253
Run by: Oryzon Genomics S.A.
People needed: 24
Starts: 2019-05-16
Expected to finish: 2020-11-12
Last updated by the study team: 2021-03-05

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Probable Alzheimer's Disease (AD) diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
MMSE score at Screening and Baseline Visits of at least 16 and not greater than 26
Evidence of the AD pathophysiological process indicated by decreased levels of amyloid antigen binding (AB) and increased levels of total Tau protein or phospho-Tau protein in cerebrospinal fluid (CSF)
Outpatient consulting a general practitioner, or a psychiatrist/neurologist/geriatrician
Knowledgeable and reliable close relative/caregiver who will accompany the patient to all clinic visits during the study
Daily treatment with the same acetylcholinesterase inhibitor on a stable dose
Fertile male and female must use highly effective contraception, from the Screening Visit until 90 days after last dose.
Signed informed consent by patient (or legal representative, if applicable) and a close relative/caregiver prior to the initiation of any study specific procedure

You may not qualify if…

Failure to perform screening or baseline examinations
Hospitalization or change of concomitant medication 1 month prior to Screening visit or during Screening Period
Clinical, laboratory or neuroimaging findings consistent with:
Other primary degenerative dementia;
Other neurodegenerative condition;
Cerebrovascular disease;
Other central nervous system diseases;
A current Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of major depression, schizophrenia or bipolar disorder
Positive results for tuberculosis, human immunodeficiency virus (HIV), hepatitis C or hepatitis B (hepatitis B surface antigen [HbsAg]) serology at the Screening Visit
Clinically significant, advanced or unstable disease that may interfere with evaluation.
Disability that may prevent the patients from completing all study requirements.
Chronic drug intake of forbidden concomitant medication.
Treatment with anti-amyloid beta or anti-Tau protein monoclonal antibodies or other disease modifying strategies within three months or five half-lives, whichever is longer, prior to the Screening Visit
Treatment with an active vaccine targeting amyloid beta or Tau protein
Suspected or known drug or alcohol abuse
Metallic implants or any other cause precluding the performance of brain MRI
Enrolment in another investigational study or intake of investigational drug within the previous 3 months since the last dose
Suicide attempt within the last year or significant risk of suicide (in the opinion of the investigator, defined as a "yes" to suicidal ideation questions 4 or 5, or answering "yes" to suicidal behavior on the Columbia-Suicide Severity Rating Scale within the past 12 months)
Any condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the study

Where it is running

Alzheimer's Research and Treatment Center — Wellington, Florida, United States
Columbus Memory Center — Columbus, Georgia, United States
Princeton Medical Institute — Princeton, New Jersey, United States
Abington Neurological Associates Ltd. — Willow Grove, Pennsylvania, United States

Full record on ClinicalTrials.gov

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