A CLINICAL STUDY TO INVESTIGATE THE EFFECTIVENESS AND SAFETY OF RO4602522 WHEN TAKEN IN ADDITION TO DONEPEZIL OR RIVASTIGMINE IN PATIENTS WITH MODERATE ALZHEIMERS DISEASE

• Conditions: Alzheimer's Disease; MedDRA version: 15.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-000943-29-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-09
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

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 between 14 and 20 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 or rivastigmine for at least 6 months prior to screening, with their dose and formulation stabilized at least 3 months prior to screening. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 315

Exclusion Criteria

1. Any neurological or psychiatric condition not specified in exceptions 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 17. History of cancer except for localized, non-recurrent treated skin cancer and stabilized prostate adenocarcinoma 18. Involvement in any other investigational trial in the last 3 months 19. Current treatment for AD other than donepezil (5 mg/day to 10 mg/day) or rivastigmine (4.6 mg/24h or 9.5 mg/24h patch). Rivastigmine (oral formulations) is permitted up to 3 months prior to screening 20. Participation at any time in an active AD vaccine study 21. Participation in a passive AD immunization = 1 year before screening 22. Recent (= 12 weeks) use of MAO inhibitors 23. Antidepressant treatment recently initiated (= 6 weeks). 24. Anti-psychotic use within 4 weeks before screening (except risperidone up to 1 mg/day, quetiapine up to 100 mg/day, olanzapine up to 5 mg / day) 25. Anxiolytics/ hypnotics use within 2 weeks before screening (except for benzodiazepines of short half-life for anxiety/sleeping disorders, if the patient is on stable dosage and regimen on them for at least 1 month prior to screening) 26. Anticonvulsant and anti-Parkinson's agents started within 2 weeks before screening 27. Anticholinergics/ antihistaminics started within 2 weeks before screening, except non-sedating antihistaminic medications 28. Recent (= 1 week) use of opioid drugs 29. Recent (= 1 week) use of cyclobenzaprine and dextromethorphan 30. Concomitant use of sympathomimetic drugs 31. Unwilling/ Unable to avoid ingesting food with high tyramine content (yeast concentrate, soy sauce, aged overripe cheese or very salty food)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified