Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

Summary

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

Timeline

Start

2013-10

Primary completion

2016-07

Completion

2016-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Idalopirdine 30 mg; p = 0.9591; Mean Difference (Final Values) 0.33 (95% CI -0.59 to 1.26); NCT01955161 ↗

registry analysis (superiority test); Placebo vs Idalopirdine 60 mg; p = 1.000; Mean Difference (Final Values) 0.05 (95% CI -0.88 to 0.98); NCT01955161 ↗

paper In patients with mild to moderate AD, the use of idalopirdine compared with placebo did not improve cognition over 24 weeks of treatment. PMID 29318278 ↗

Publications

• Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.
• Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.
• Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Idalopirdine	Small molecule	30 mg	Oral
Subject	Idalopirdine	Small molecule	60 mg	Oral

Indications