Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease with Option for up to an Additional Two Years of Treatment and up to Three Years of an Open-Label Extension with Active Study Treatment
- Conditions
- Alzheimer's diseasedementia10011305
- Registration Number
- NL-OMON47181
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
- Adult patients, 50-85 years of age;- Patients with prodromal Alzheimer's Disease who are not receiving memantine or cholinesterase inhibitors;- Has a study partner who is able to provide accurate information as to the patient's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion;- Has had sufficient education or work experience to exclude mental retardation;- Study partner has noticed a recent gradual decrease in patient's memory (e.g. over the last 12 months), which the patient may or may not be aware of;- Screening MMSE score of 24 or above;- Subjects who received double-blind treatment during either Part 1 or Part 2
prior to the futility analysis, and had at least one follow-up/drop-out visit will be
eligible to enter Part 3.
- Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning ;- A history of stroke ;- A documented history of transient ischemic attack within the last 12 months ;- History of schizophrenia, schizoaffective or bipolar disorder ;- Currently meets criteria for major depression ;- Within the last 2 years, unstable or clinical significant cardiovascular disease (e.g. myocardial infarction, angina pectoris)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Open-label extension: long-term and short-term safety and tolerability</p><br>
- Secondary Outcome Measures
Name Time Method