Roflumilast to Treat Cognitive Sequela After Stroke

Sponsor
Maastricht University
Study ID
NCT04854811
Phase
PHASE2
Status
Completed

Conditions

  • Cerebrovascular Disorders
  • Drug Intervention
  • Functional Recovery
  • Memory

Eligibility Criteria

Sex
ALL
Age
41 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The aim of the current project is to validate the effects of chronic rolflumilast treatment (12 weeks) on cognitive functions (i.e. episodic memory) by means of behavioral tasks, in people suffering from cognitive impairments at least 1 year after stroke. Secondarily, the effects of roflumilast on daily activities and well-being will be assessed.

Key Dates

Start date
Jul 7, 2021
Status verified
Jan 2024
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo oral capsule, once daily for 12 weeks
  • Experimental: Roflumilast (100 microgram)
    once daily for 12 weeks

Primary Outcome Measure

Verbal Learning Test (VLT) Verbal Learning Test (VLT) (15 words) (delayed recall) [ Time Frame: Change from baseline to 12 weeks of chronic intake ] Verbal Learning Test (VLT) [ Time Frame: Change from baseline to 12 weeks of chronic intake ]

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