Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients (NCT04658654) | Clinical Trial Compass
UnknownPhase 2
Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients
Netherlands81 participantsStarted 2021-11-19
Plain-language summary
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.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 50 to 90 years of age
* Willingness (including the informal caregiver) to sign an informed consent
* Body mass index (BMI) between 18.5 and 35
* MMSE of 20 or higher
* Clinical (amnestic)MCI or mild dementia diagnosis
* Memory performance on the delayed recall in the clinically relevant 15 words VLT of 1 or more SD below the average
* Clinical dementia rating (CDR) scale total score of 0.5 or 1
* Fazekas of 2 or lower
Exclusion Criteria:
* Normal Pressure Hydrocephalus (NPH)
* Fazekas of 3 or higher
* Morbus Huntington
* Parkinson's disease
* HIV/AIDS
* Hepatitis C \& B
* Recent Transient Ischemic Attack (TIA) (\< 2 years)
* Cerebrovascular Accident (CVA) (\< 2 years)
* TIA/CVA followed by cognitive decline (within 3 months)
* Chronic Obstructive Pulmonary Disease (COPD) gold criteria 3 or 4 and severe asthma
* History of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime)
* Current radiotherapy
* 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 heredita…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Verbal Learning Test (VLT) (15 words)
Timeframe: Change from baseline to 24 weeks of chronic intake