Currently there is an unmet clinical need to treat patients living with Parkinson disease with mild cognitive impairment (PD-MCI). Mild cognitive impairment (MCI) in people living with Parkinson’s is widespread and has significant clinical effects. At the moment there is no treatment available for PD-MCI. In fact, the underlying pathology of MCI in Parkinson's suggests that nicotinic agonists are specifically relevant for this condition, and there is sufficient preliminary (pre-)clinical evidence in support of this hypothesis. Hence, the major aim of the project PD-MIND is to identify the potential of the nicotinic α7 agonist AZD0328 in a randomized, placebo-controlled, parallel group, international multicentre study on cognitive function in people diagnosed with PD-MCI.
PD-MIND hopes to find early proof-of-concept for new mechanisms with the potential to rapidly bring a novel drug to patients with this high unmet need. The project exploits a novel target in a large population of 1.2 million people living with Parkinson's already in Europe alone. PD-MCI-diagnosed people and their carers experience a significantly reduced quality of life. People living with PD-MCI also undergo a rather shorter time to developing dementia. In this regard, the development of the first ever drug to effectively improve cognitive functions in PD-MCI-diagnosed people would deliver important socioeconomic and clinical impacts.
PD-MIND’s ambition is to determine the potential effectiveness of a nicotinic receptor agonist on cognitive decline as a primary outcome measure in PD-MCI.
The project could result in the first systematic evidence of improvement in PD-MCI patients, because the project aims to develop a drug for the first phase 3 clinical trial for PD-MCI. Since Parkinson's affects 1% of European citizens over 65 years, this envisioned outcome is expected to have a huge socioeconomic and clinical impact.
Secondly, PD-MIND strives, even in the context of a drug repurposing program, to optimise drug development timelines. Generally, trial duration will be kept to a maximum of 22 months, thanks to the use of highly experienced, large recruiting centers and short follow-up sessions necessary. In comparison with conventional drug (repurposing) developmental programmes wherein phase 2 and phase 3 trial period span 8 years or more, PD-MIND allows an expected time to clinic/market of 6 years only, i.e. a 2 years gain.