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Status:

COMPLETED

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

Lead Sponsor:

Oryzon Genomics S.A.

Collaborating Sponsors:

Alzheimer's Drug Discovery Foundation

Conditions:

Mild to Moderate Alzheimer's Disease

Eligibility:

All Genders

50-85 years

Phase:

PHASE2

Brief Summary

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

Detailed Description

This phase IIa study is a double-blind, randomized, parallel-group and multicenter study with a placebo-controlled 24-week treatment period followed by a no placebo-controlled 24-week extension period...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

May 16 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 12 2020

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT03867253

Start Date

May 16 2019

End Date

November 12 2020

Last Update

March 5 2021

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Alzheimer's Research and Treatment Center

Wellington, Florida, United States, 33414

2

Columbus Memory Center

Columbus, Georgia, United States, 31909

3

Princeton Medical Institute

Princeton, New Jersey, United States, 08540

4

Abington Neurological Associates Ltd.

Willow Grove, Pennsylvania, United States, 191090