The aim of the current project is to validate whether chronic intake (24 weeks) roflumilast (PDE4 inhibitor) can improve cognition in patients with (amnestic) mild cognitive impairment (MCI) and in patients with mild dementia. The project will demonstrate whether episodic memory, but also attention, information processing or executive function improves with chronic administration of roflumilast in (a)MCI and mild dementia patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
81
chronic intervention (24 weeks): roflumilast capsule
Pill with inactive ingredients to mimic same appearance of roflumilast capsule
University of Maastricht, Faculty of Psychology and Neuropsychology
Maastricht, Netherlands
RECRUITINGVerbal Learning Test (VLT) (15 words)
Time frame: Change from baseline to 24 weeks of chronic intake
Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)
Time frame: Change from baseline to 24 weeks of chronic intake
Mini Mental State Examination (MMSE)
Time frame: Change from baseline to 24 weeks of chronic intake
Pattern Separation Task
Time frame: Change from baseline to 24 weeks of chronic intake
Trail-Making Test (TMT)
Time frame: Change from baseline to 24 weeks of chronic intake
Letter Digit Substitution Test (LDST)
Time frame: Change from baseline to 24 weeks of chronic intake
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline to 24 weeks of chronic intake
Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale
Time frame: Change from baseline to 24 weeks of chronic intake
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline to 24 weeks of chronic intake
QoL-AD
Time frame: Change from baseline to 24 weeks of chronic intake
EuroQol
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Time frame: Change from baseline to 24 weeks of chronic intake
Boston Naming Task
Time frame: Change from baseline to 24 weeks of chronic intake