cerebrovascular accident stroke
Conditions
Interventions
The study will consist of 2 arms (N = 50 per arm): placebo and 100 µg
roflumilast. The duration of treatment is planned for 3 months
in addition, all participants will train their cognitive function
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -41 to 70 years of age; -willingness to sign an IC; -Objective cognitive complaint: memory performance on the delayed recall in the 15 words VWLT below the normative score (corrected for education, sex and age) (see Van der Elst, van Boxtel, van Breukelen, & Jolles, 2005).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participating in this study: Normal Pressure Hydrocephalus (NPH), Morbus Huntington, Parkinson's disease, HIV/AIDS and Hepatitis B and C, recent Transient Ischemic Attack (TIA), COPD Gold 3 and 4, history of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime), current affective disorder (i.e. anxiety or major depression), cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation. Other exclusion criteria are current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, Methylenedioxymethamphetamine (MDMA) and cocaine. Roflumilast is contraindicated in patients with moderate to severe liver impairment, accordingly patients with moderate or major liver impairments will be excluded (e.g. Child-Pugh B and C). Use of medication showing strong inhibition of either CYP3A4 (e.g. clarithromycin, antihistamines) or CYP1A2 (e.g. fluvoxamine, ciprofloxacin and other fluoroquinolones) is also an exclusion criterion because of interference with roflumilast metabolism resulting in reduced therapeutic effectiveness of roflumilast. Individuals with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption will be excluded, as both the placebo and roflumilast contain lactose monohydrate. Additionally, during the period of the present study, participants are not allowed to participate in other drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: The delayed recall performance in the Verbal Word Learning Task is used as the primary outcome measure since our previous study with roflumilast showed effects in this task. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: Cognitive performance: the total score of the Rivermead Behavioural Memory Test, Everyday Memory Questionnaire-Revised, Digit-Symbol Substitution Test, Trail Making Test, reaction time test (simple reaction time, movement time). Mood and well-being: Utrechtse Schaal voor Evaluatie van Revalidatie-Participatie, and the total mood score of the Hospital Anxiety and Depression Scale questionnaire. | — |
Countries
Netherlands
Outcome results
None listed