Last updated on April 2013

A Phase Ii, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Investigate The Efficacy And Safety Of Ro4602522 Added To The Background Therapy Of The Acetylcholinesterase Inhibitors Donepezil Or Rivastigmine In Patients With Moderate Severity Alzheimer's Disease


Brief description of study

A Phase Ii, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Investigate The Efficacy And Safety Of Ro4602522 Added To The Background Therapy Of The Acetylcholinesterase Inhibitors Donepezil Or Rivastigmine In Patients With Moderate Severity Alzheimer's Disease

Detailed Study Description

Patient Inclusion Criteria:

  • Ages: over 50-90
  • Male/Female
  • 12 Month Long Clinical Trial
  • MMSE score 14-20
  • Adult patients, 50-90 years of age inclusive at time of screening
  • Probable Alzheimer disease, 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
  • MMSE score at screening between 14 and 20, inclusive
  • Body mass index (BMI) between 18 and 36 kg/m2 (inclusive) at screening
  • Modified Hachinski Ischemia Score of
  • Patients with Cornell Scale for Depression in Dementia (CSDD) scores
  • Receiving treatment with donepezil or rivastigmine for at least 6 months before baseline, with their dose and formulation stabilized at least 3 months before screening. For donepezil the dose must be 5 to 10 mg p.o. daily; for rivastigmine, though patients on tablets prior to 3 months are eligible, they must be on the patch formulation only, in a stable dose (4.6 mg/24h or 9.5 mg/24h patch) for the 3 months before screening
  • Females of childbearing potential must have a negative pregnancy test and must agree to use effective contraception
  • Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane)
  • Have a reliable caregiver or some other identified responsible person who has frequent contact with the patient

Patient Exclusion Criteria:

  • Any neurological or psychiatric condition not specified in exceptions in protocol
  • Background of mental retardation
  • Uncontrolled behavioral symptoms incompatible with compliance or evaluability
  • Alcohol and/or substance abuse or dependence (DSM-IV-TR) in the past 2 years, except nicotine use which is allowed. However, smokers treated with nicotine replacement therapy or bupropion are excluded
  • Unstable or poorly controlled hypertension as assessed by the investigator
  • Unstable or clinically significant cardiovascular disease that could be expected to progress, recur, or change during study period to such an extent that it could bias the assessment of the clinical or mental status of the patient
  • Inadequate hepatic, renal or thyroid function
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Poorly controlled diabetes
  • Requiring nursing home care
  • Current treatment for AD other than donepezil or rivastigmine
  • Participation at any time in an active AD vaccine study
  • Participation in a passive AD immunization study less than 1 year before screening
  • Psychotropic medication as defined by protocol

Clinical Study Identifier: TX136837

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Axiom Clinical Research of Florida

2919 Swann Ave, Suite 105A Tampa, FL USA
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Recruitment Status: Open


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