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 an additional two years of treatment

Phase 2

Completed

• Conditions: Alzheimer's disease; dementia; 10011305

• Registration Number: NL-OMON39809
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

- 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

Exclusion Criteria

- 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>Primary objective:<br /><br><br /><br>Evaluate the effect of two doses versus placebo gantenerumab subcutaneous<br /><br>injections on the change in Clinical Dementia Rating Sum of Boxes scale (CDR<br /><br>SOB), a global measure of cognition and functional capacity</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br><br /><br>To evaluate the efficacy, safety and tolerability of gantenerumab placebo<br /><br>subcutaneous injections<br /><br><br /><br>See also page 2 in the protocol</p><br>