PD-MIND
Research type
Research Study
Full title
Parkinson’s Disease with Mild cognitive Impairment treated with Nicotinic agonist Drug
IRAS ID
263633
Contact name
Dag Aarsland
Contact email
Sponsor organisation
King's College London
Eudract number
2019-002423-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Mild cognitive impairment (MCI) in Parkinson's Disease (PD), referred to as PD-MCI, affects approximately 25% of non-demented PD patients. PD-MCI is associated with significantly reduced quality of life, excess disability, care-giver stress, and increased health-related costs. As a major risk factor for subsequent dementia, successful treatment of PD-MCI may delay dementia development, in addition to reducing the adverse impact in affected individuals, care-givers and wider society. Consequently, PD-MCI is an important treatment target. Despite this, there is currently no treatment available, and represents a significant unmet clinical need.
The purpose of this study is to test whether AZD0328, a selective α7 nicotinic receptor agonist, is superior to placebo in persons with PD-MCI, on cognitive, motor and other health-related outcome measures, after 12-weeks treatment. Other aims of the study include assessing MRI imaging bio-markers as potential predictors of response and as marker of target involvement and blood-based bio-markers to explore potential disease modification and detect markers relevant for neuro-protection.
160 individuals with PD-MCI will be recruited across study sites in Europe. 80 participants will be randomly allocated to the active group and receive the study medication, versus 80 participants randomly allocated to control group and receive placebo. The maximum study duration per participant is approximately 20 weeks; with a treatment period of 12 weeks.
Study participants will undergo in-person assessments at screening, baseline, week 3, week 6, and week 12. Study procedures include questionnaires and computerised cognitive tasks. At week 16 we will conduct an over-the-phone check-in and participants can complete computer-based cognitive tasks remotely, if they have access to a computer. A subset of 90 participants will have MRI scans before and after 12-weeks of treatment.
The study is being funded by an EU IMI grant, Michael J. Fox Foundation, and Parkinson's UK. AstraZeneca is providing IMP and placebo as an in-kind contribution.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0074
Date of REC Opinion
23 Mar 2021
REC opinion
Further Information Favourable Opinion