Data from Lundbeck’s Phase 2 and 3 clinical trials of idalopirdine in Alzheimer’s patients, will be made available to researchers worldwide through the Critical Path for Alzheimer’s Disease (CPAD) consortium database, held by The Critical Path Institute (C-Path).
The Phase 3 studies failed to meet their primary goals of improving cognitive abilities in those given this treatment.
C-Path is an independent, nonprofit, public-private partnership with the U.S. Food and Drug Administration (FDA) that through consortia like CPAD, aims to bring together experts from regulatory authorities, industry, and patient advocacy organizations to speed and improve the process of therapy development for diseases that include Alzheimer’s.
“We are delighted with this opportunity to share data with CPAD, ensuring that researchers can get the most out of them in advancing the understanding of Alzheimer’s and how to best develop new treatments,” Mads Dalsgaard, senior vice president, experimental medicine & clinical development at Lundbeck, said in a press release.
Idalopirdine is an antagonist of the serotonin 6 receptor jointly developed by Lundbeck and Otsuka Pharmaceutical. By blocking this seratonin receptor — a process that would affect a range of neurotransmitters besides serotonin — idalopirdine was thought to aid cognition. In this regard, the compound was designed to treat Alzheimer’s symptoms rather than alter the course of the disease.
While a Phase 2 trial (NCT01019421) suggested that idalopirdine given alongside Aricept (donepezil) could improve cognition in Alzheimer’s patients, three Phase 3 clinical trials (NCT01955161, NCT02006641, and NCT02006654) have failed to reproduce the same benefits.
“Lundbeck and C-Path recognize the hard work to generate these data and contributions of the many patients with Alzheimer disease, their relatives and caregivers, and the investigators who took part in these trials,” said Joseph Scheeren, PharmD, C-Path president and CEO.
Under the collaboration with C-Path, Lundbeck will contribute information to CPAD’s database about the trials’ design, and patient data on the more than 2,500 people who participated in the trials. These data include disease progression and the effects of the medication. Data will be integrated and managed by CPAD, with support from C-Path’s Data Collaboration Center to advance future research efforts.
Although idalopirdine failed to show effectiveness against Alzheimer’s disease, the shared trial data will help CPAD develop a model of disease progression across the entire spectrum of Alzheimer’s, from its earliest to late stages.
These types of contributions help to advance scientists’ understanding of Alzheimer’s, and may help in developing tools and methods to optimize clinical trials, and to facilitate the regulatory review of new therapies for Alzheimer’s disease.
“We are proud to contribute to this work, not only through our own drug development activities, but also in this unique collaboration,” Dalsgaard added.
CPAD’s database currently contains data from more than 14,500 Alzheimer’s disease patients. CPAD is also exploring the possibility of acquiring datasets from other sources, and expects to grow the database to include more than 40,000 patient-level records in the coming months.
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