Cerebrovascular accident
Conditions
Interventions
Trade Name: Daxas (EU)
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
Hersenstichting
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: - 40 to 70 years of age; - willingness to sign an IC; - Objective cognitive complaint: memory performance on the delayed recall in the 15 words VWLT of below the normative score (corrected for education, sex and age) (see Van der Elst, van Boxtel, van Breukelen, & Jolles, 2005). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
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, Hepatitis B and C, recent Transient Ischemic Attack (TIA), COPD Type 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 |
|---|---|
| Main Objective: The primary aim of this study is to show that roflumilast can improve verbal memory performance in people who suffered a stroke. We will use the Verbal Word Learning Test (VWLT) and measure the delayed recall performance (after about 30 min). This test has been found to be sensitive for the positive effects of roflumilast in our previous studies. The tests measures episodic memory that reflects memory for personal events.;Secondary Objective: Measuring effects on other cognitive functions (reaction time, attention, executive functions), on aspects of every day memory, activities in daily living, and well-being. We will use the Rivermead Behavioural Memory Test (RBMT), Letter-Digit Substitution Test (LDST), Trail Making Test (TMT) and a reaction time test (simple reaction time, movement time), the Hospital Anxiety and Depression Scale (Depression subscale, HADS-D), the Everyday Memory Questionnaire-Revised (EMQ-R), and a test for daily participation (Utrechtse Schaal voor Evaluatie van Revalidatie-Participatie (USER-P)). ;Primary end point(s): Expected increase in verbal learning task (VWLT) recall in words in the delayed condition (15 words) at 3 months;Timepoint(s) of evaluation of this end point: -Baseline -acute -at 1.5 months of chronic intake of roflumilast -at 3 months of chronic intake of roflumilast -3 months follow-up post 3 months of chronic intake of roflumilast | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): decrease in reaction time (simple reaction time, movement time), decrease in completion time and number of errors on the LDST and TMT, improved score on the RBMT, lower score (less complaints) on EMQ-R and the HADS-D, and higher participation score (higher frequency and satisfaction, less experience of limitations) on USER-P ;Timepoint(s) of evaluation of this end point: -Baseline -acute -at 1.5 months of chronic intake of roflumilast -at 3 months of chronic intake of roflumilast -3 months follow-up post 3 months of chronic intake of roflumilast | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Maastricht University
Outcome results
None listed