Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)
Summary
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40 countries for Alzheimer's disease to date, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico. Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo. Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day) for the majority of the study. At every regular visit scheduled every three months, patients will be given basic efficacy and safety assessments. These assessments will include evaluation of adverse events, vital signs, activities of daily living, and clinical staging scales to determine if the subject may have converted to dementia.
Timeline
- Start
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- Primary completion
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- Completion
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Outcome
Missed primary endpoint
paper 17.3% of patients on rivastigmine and 21.4% on placebo progressed to AD (hazard ratio 0.85 [95% CI 0.64-1.12]; p=0.225). PMID 17509485 ↗
paper There was no significant difference between the rivastigmine and placebo groups on the standardised Z score for the cognitive test battery PMID 17509485 ↗
paper There was no significant benefit of rivastigmine on the progression rate to AD or on cognitive function over 4 years. PMID 17509485 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivastigmine | Small molecule | 6 mg | — |