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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo oral capsule, once daily for 24 weeks |
|
| Roflumilast 50ug | Experimental | Roflumilast (50 microgram) oral capsule, once daily for 24 weeks |
|
| Roflumilast 100ug | Experimental | Roflumilast (100 microgram) oral capsule, once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | chronic intervention (24 weeks): roflumilast capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Learning Test (VLT) (15 words) | Change from baseline to 24 weeks of chronic intake |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale) | Change from baseline to 24 weeks of chronic intake | |
| Mini Mental State Examination (MMSE) | Change from baseline to 24 weeks of chronic intake |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to Alzheimer's disease (AD) | 24 weeks | |
| Pharmacokinetic validation of roflumilast and its active metabolite roflumilast N-Oxide in plasma | Acute, 12 weeks chronic intake and 24 weeks chronic intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Possemis, MSc. | Contact | +31 (0)43 388 1022 | n.possemis@maastrichtuniversity.nl | |
| Inez Ramakers, Dr. | Contact | i.ramakers@maastrichtuniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| Inez Ramakers, Dr. | Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands. | Principal Investigator |
| Frans Verhey, Prof. Dr. | Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maastricht, Faculty of Psychology and Neuropsychology | Recruiting | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38438923 | Derived | Possemis N, Verhey F, Prickaerts J, Blokland A, Ramakers I. A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer's disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial. Trials. 2024 Mar 4;25(1):162. doi: 10.1186/s13063-024-08001-3. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
| D058988 | Phosphodiesterase 4 Inhibitors |
| ID | Term |
|---|---|
| D010726 | Phosphodiesterase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Placebo oral tablet | Drug | Pill with inactive ingredients to mimic same appearance of roflumilast capsule |
|
|
| Pattern Separation Task | Change from baseline to 24 weeks of chronic intake |
| Trail-Making Test (TMT) | Change from baseline to 24 weeks of chronic intake |
| Letter Digit Substitution Test (LDST) | Change from baseline to 24 weeks of chronic intake |
| Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 24 weeks of chronic intake |
| Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale | Change from baseline to 24 weeks of chronic intake |
| Neuropsychiatric Inventory (NPI) | Change from baseline to 24 weeks of chronic intake |
| QoL-AD | Change from baseline to 24 weeks of chronic intake |
| EuroQol | Change from baseline to 24 weeks of chronic intake |
| Boston Naming Task | Change from baseline to 24 weeks of chronic intake |
| Tau in tears | Change from baseline to 24 weeks of chronic intake |
| Arjan Blokland, Prof. Dr. | Neuropsychology & Psychopharmacology, FPN, Maastricht University, The Netherlands | Principal Investigator |
| Jos Prickaerts, Prof. Dr. | Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands. | Principal Investigator |
| D020164 | Chemical Actions and Uses |