Anavex Life Sciences has launched an extension study — called ATTENTION-AD — to investigate the long-term safety and efficacy of Anavex 2-73 in delaying cognitive decline in people with early Alzheimer’s disease.
Eligible patients are those now taking part in the company’s 48-week ANAVEX2-73-AD-004 study underway in Australia.
“This is an important development as the patients who have completed the main study … are consistently expressing the wish to gain ongoing access to this investigational therapy,” Stephen Macfarlane, head of clinical services at the Dementia Centre of HammondCare and principal investigator for both trials, said in a press release.
Anavex 2-73 (blarcamesine) is an investigational oral disease-modifying therapy that binds to and activates a cell receptor called Sigma-1 that’s known to have neuroprotective effects.
Specifically, Anavex 2-73 is thought to help restore cellular balance by targeting protein misfolding (which prevents them from working as intended), oxidative stress ( oxygen molecules with free radicals, or unpaired electrons, that damage cells), mitochondrial dysfunction, inflammation, and cellular stress.
Results from an earlier, open-label Phase 2a trial and its ongoing extension study (NCT02244541 and NCT02756858) showed that treatment was safe, with 50 mg Anavex 2-73 significantly slowing cognitive decline in people with mild to moderate Alzheimer’s.
The current Phase 2b/3 (NCT03790709), still enrolling, is exploring two doses of oral Anavex 2-73 (a middle and high dose) against placebo for almost one year in up to 450 people (ages 60 to 85) with with mild cognitive impairment or early stage mild dementia due to Alzheimer’s disease.
Researchers will evaluate treatment effectiveness by measuring changes from the study’s start in patients’ cognitive functions and ability to perform daily life activities after 48 weeks. They will also explore changes in sleep patterns and dementia symptoms, and treatment safety, compared to people given placebo.
Those who complete the main study and its follow-up examinations will have the opportunity to roll into ATTENTION-AD, the open-label extension study, and continue or begin treatment with Anavex 2-73 for two years.
“People living with Alzheimer’s disease desperately need new therapies and ATTENTION-AD reflects our commitment to the patients who participated in the Phase 2b/3 ANAVEX 2-73-AD-004 study and who have contributed enormously to the development of a potential new medicine for patients with Early Alzheimer’s disease,” said Christopher U. Missling, PhD, the company’s CEO.
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