Status:
COMPLETED
Roflumilast to Treat Cognitive Sequela After Stroke
Lead Sponsor:
Maastricht University
Collaborating Sponsors:
Netherlands Brain Foundation
Conditions:
Cerebrovascular Disorders
Memory
Eligibility:
All Genders
41-70 years
Phase:
PHASE2
Brief Summary
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 f...
Detailed Description
Rationale: In the Netherlands there are about 400.000 people who suffer from long-term consequences of a stroke. In the first months, spontaneous neurological recovery can take place, but there is har...
Eligibility Criteria
Inclusion
- Willingness to sign an informed consent
- Body mass index (BMI) between 18.5 and 35
- Suffered a stroke at least one year ago; and at the age of 40 or later
- 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)
Exclusion
- Normal Pressure Hydrocephalus (NPH)
- Morbus Huntington
- Parkinson's disease
- HIV/AIDS
- Hepatitis C \& B
- Recent Transient Ischemic Attack (TIA) (\< 1 years)
- Cerebrovascular Accident (\<1 years)
- Chronic Obstructive Pulmonary Disease (COPD) type Gold 3 and 4
- History of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime)
- Risk of suicidal behaviour
- 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.
- Current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, MDMA and cocaine
- 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 or CYP1A2
- Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients participating in other drug studies
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04854811
Start Date
July 7 2021
End Date
December 1 2023
Last Update
January 17 2024
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 6200 MD