IRLAB starts Phase II study with IRL752 for the treatment of Parkinson’s disease dementia
The randomized, double blind and placebo controlled study with the drug candidate IRL752 has been initiated with the first dosing. The study aims to provide information on the safety, tolerability and efficacy of IRL752 in patients with Parkinson’s disease dementia. Today, there is a lack of effective treatment options for these patients and thus, the medical needs are large. The study, which is carried out in Scandinavia, is planned to recruit about 40 patients and a have a treatment duration of four weeks. The study is estimated to be concluded during the second quarter of 2018.
The Phase II study is designed to study effects of IRL752 on cognitive and motor symptoms in patients with Parkinson’s disease dementia. The study also includes collection of data from families and caregivers to provide information on how treatment affects patient’s wellbeing and daily living. The primary study objective is to study safety and tolerability of IRL752 in this patient population.
Pre-clinical studies have shown that IRL752 increases the levels of the neurotransmitters dopamine, norepinephrine and acetylcholine in the synapses of the frontal cortex. These neurotransmitters are essential for executive and cognitive function. In patients with Parkinson’s disease dependent dementia these transmitters are reduced.
In the previously conducted Phase I studies, IRL752 was found to be well tolerated and with a very good safety profile. No effects on vital signs or laboratory analyses collected in the studies was observed. IRL752 displays dose linear pharmacokinetics. Food intake does not affect uptake or distribution of the compound.