An initial analysis of the Dominantly Inherited Alzheimer’s Network-Trials Unit (DIAN-TU) has revealed that solanezumab and gantenerumab did not slow memory loss or cognitive decline in people with autosomal dominant Alzheimer’s disease.
The Phase II/III international trial indicated that neither drug met the primary outcome of the study (i.e., slowing of cognitive decline as measured by multiple tests of thinking and memory).
“Although the drugs we evaluated were not successful, the trial will move us forward in understanding Alzheimer’s,” commented principal investigator, Randall Bateman (Washington University School of Medicine, MO, USA). “The trial’s innovative design – developed in collaboration with a consortium of pharmaceutical companies, the National Institutes of Health (NIH), regulatory agencies and academic leaders – will make advances for future Alzheimer’s trials. Ongoing and continued research and trials will bring us closer to our goal to stop Alzheimer’s. We will continue until we are successful.”
All participants within the trial were recruited from families that carry a genetic mutation that causes early-onset Alzheimer’s dementia. People who inherit the mutation are all guaranteed to develop symptoms at approximately the same age as their parents. The researchers recruited people who were expected to develop symptoms within 15 years of study enrolment who already had very mild symptoms of memory loss and cognitive decline.
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The study followed 194 individuals for up to 7 years (average of 5 years) and aimed to determine whether either solanezumab or gantenerumab could slow, stop or prevent memory loss and cognitive decline related to Alzheimer’s.
Each participant was randomly assigned to receive solanezumab, gantenerumab or a placebo. In addition to this, individuals who were in the same family but who did not have the Alzheimer’s mutation were also included for comparison. As part of the trial, the doses of solanezumab and gantenerumab were increased to enhance their potential beneficial effects.
Whilst the primary goal of the study was to evaluate whether the drugs could slow or delay memory loss and cognitive decline, the team also obtained brain scans and samples of blood and cerebrospinal fluid in order to examine biological signs of the disease. These samples are now being analyzed to better understand how the disease develops and how it can ultimately be stopped.
A more detailed analysis of the trial’s data will be presented for the first time at the Advances in Alzheimer’s and Parkinson’s Therapies Annual Meeting (2 April, Vienna, Austria), followed by presentations at the Alzheimer’s Association International Conference (26–30 July, Amsterdam, The Netherlands).