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
-
- STATUS
- Recruiting
Summary
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
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
Details
| Clinical Study Identifier | TX136837 |
|---|---|
| Last Modified on | 25 March 2021 |
Eligibility
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer