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Clinical Trials/EUCTR2012-000943-29-GB
EUCTR2012-000943-29-GBActive, not recruitingPhase 1

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RO4602522 ADDED TO BACKGROUND ALZHEIMER’S DISEASE THERAPY IN PATIENTS WITH MODERATE SEVERITY ALZHEIMER’S DISEASE

F. Hoffmann-La Roche Ltd0 sites540 target enrollmentStarted: August 21, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
540
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1. Probable AD, based on the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS)/Alzheimer’s Disease and Related Disorders Association (ADRDA) and DSM-IV-TR criteria.
  • •2. 50-90 years of age
  • •3. MMSE score at screening between 13 and 20, inclusive
  • •4. MRI supports a diagnosis of AD, with no evidence of other disease likely to account for the subject’s dementia.
  • •5. Body mass index (BMI) between 18 and 36.
  • •6. Modified Hachinski Ischemia Score of =4.
  • •7. Patients with CSDD scores =13.
  • •8. Receiving treatment with donepezil, rivastigmine, galantamine or any of these AChEIs in combination with memantine for at least 4 months, with their dose and formulation stabilized for at least 3 months prior to screening. All formulation and dosages are allowed except donezepil 23 mg (alone or in combination).
  • •9. Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
  • •10. Have a caregiver who has frequent contact with the patient, who is considered reliable, who can accompany patient to study visits and help with protocol procedures, and who is also able and willing to provide input for completing the caregiver scales and sign the caregiver consent form.
  • •11. Females of childbearing potential must have a negative pregnancy test and must agree to use effective contraception
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 124
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 371

Exclusion Criteria

  • •1. Any neurological or psychiatric condition that may currently or during the course of the study impair cognition or functioning that is not associated with Alzheimer's disease
  • •2. Background of mental retardation
  • •3. At risk of suicide
  • •4. Uncontrolled behavioral symptoms
  • •5. Alcohol and/or substance abuse or dependence in the past 2 years, except nicotine use
  • •6. Preexisting neuropathy
  • •7. Unstable or poorly controlled hypertension and/or cardiovascular disease
  • •8. Clinically relevant ECG abnormality
  • •9. Bradycardia
  • •10. Aspartate aminotransferase, alanine aminotransferase or total bilirubin =1.5 times the upper limit of normal
  • •11. HIV positive, history of Hepatitis B infection within the past year, or history of Hepatitis C infection
  • •12. Hepatitis B virus surface Antigen (HBsAg) and/or Hepatitis C antibodies (HepCAb) positive
  • •13. Abnormal thyroid function tests
  • •14. Poorly controlled diabetes
  • •15. Severe renal impairment
  • •16. Requiring nursing home care. Patients living in assisted living facilities are allowed if a reliable caregiver is available (see inclusion criteria)
  • •17. History of cancer except if considered likely to be cured as documented by an oncologist / surgeon or in the case of non-melanoma skin cancers and prostate adenocarcinoma if there has been no significant progression over the last 2 years
  • •18. Involvement in any other investigational trial in the last 3 months
  • •19. Current treatment for AD other than those listed in inclusion criteria
  • •20. Participation at any time in an active AD vaccine study
  • •21. Participation in a passive AD immunization study less than 1 year before screening, with exceptions as per protocol
  • •22. Recent (= 12 weeks) use of MAO inhibitors
  • •23. Antidepressant treatment recently initiated (= 6 weeks).
  • •24. Psychotropic medication as defined by protocol
  • •25. Unwilling/ Unable to avoid ingesting food with high tyramine content (yeast concentrate, soy sauce, aged overripe cheese or very salty food)

Investigators

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