Mild Cognitive ImpairmentPhase 2ROMEMANCT04658654
Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients
A Phase 2 study testing Roflumilast in people with Mild Cognitive Impairment and Mild Dementia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Amnestic Mild Cognitive Disorder
- What is being tested?
- Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Nov 2021to Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Normal Pressure Hydrocephalus (NPH)
- Fazekas of 3 or higher
- Morbus Huntington
- Parkinson's disease
- HIV/AIDS
- Hepatitis C \& B
Show all 20Show fewer
- 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 hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients participating in other drug studies
- If patient does not have the possibility to be accompanied by the same informal caregiver during all test days
Trial locations and contacts
1 site in 1 country.
Inez Ramakers, Dr. contact
Netherlands1 site, 1 recruiting
- Recruiting
University of Maastricht, Faculty of Psychology and Neuropsychology
Maastricht
Nina Possemis, MSc, n.possemis@maastrichtuniveristy.nl
About this study
Official title: A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia
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.
- Being tested
- Roflumilast, Placebo oral tablet
- Keywords
- MCI, amnestic MCI, mild dementia
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
Also called EU: Daxas, US: Daliresp, PDE4 inhibitor
chronic intervention (24 weeks): roflumilast capsule
Placebo oral tabletDrug
Also called Placebo
Pill with inactive ingredients to mimic same appearance of roflumilast capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo oral capsule, once daily for 24 weeks Receives: Drug: Placebo oral tablet |
| Roflumilast 50ug | Experimental | Roflumilast (50 microgram) oral capsule, once daily for 24 weeks Receives: Drug: Roflumilast |
| Roflumilast 100ug | Experimental | Roflumilast (100 microgram) oral capsule, once daily for 24 weeks Receives: Drug: Roflumilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Learning Test (VLT) (15 words)
Measured: Change from baseline to 24 weeks of chronic intake
Secondary outcomes (11)
Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)
Measured: Change from baseline to 24 weeks of chronic intake
Mini Mental State Examination (MMSE)
Measured: Change from baseline to 24 weeks of chronic intake
Pattern Separation Task
Measured: Change from baseline to 24 weeks of chronic intake
Trail-Making Test (TMT)
Measured: Change from baseline to 24 weeks of chronic intake
Letter Digit Substitution Test (LDST)
Measured: Change from baseline to 24 weeks of chronic intake
Hospital Anxiety and Depression Scale (HADS)
Measured: Change from baseline to 24 weeks of chronic intake
Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale
Measured: Change from baseline to 24 weeks of chronic intake
Neuropsychiatric Inventory (NPI)
Measured: Change from baseline to 24 weeks of chronic intake
QoL-AD
Measured: Change from baseline to 24 weeks of chronic intake
EuroQol
Measured: Change from baseline to 24 weeks of chronic intake
Boston Naming Task
Measured: Change from baseline to 24 weeks of chronic intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start19 Nov 2021
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inez Ramakers, Dr., Principal investigator, Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.Frans Verhey, Prof. Dr., Study director, Psychiatry and Neuropsychology, FHML, Maastricht University, the NetherlandsArjan Blokland, Prof. Dr., Principal investigator, Neuropsychology & Psychopharmacology, FPN, Maastricht University, The NetherlandsJos Prickaerts, Prof. Dr., Principal investigator, Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658654
- Sponsor's protocol ID
- 72476
- Acronym
- ROMEMA
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38438923
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia
- ClinicalTrials.gov ID
- NCT04658654
- Acronym / sponsor ID
- ROMEMA / 72476
- Keywords
- MCI, amnestic MCI, mild dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo oral capsule, once daily for 24 weeks |
| Roflumilast 50ug | Experimental | Drug: RoflumilastRoflumilast (50 microgram) oral capsule, once daily for 24 weeks |
| Roflumilast 100ug | Experimental | Drug: RoflumilastRoflumilast (100 microgram) oral capsule, once daily for 24 weeks |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- Normal Pressure Hydrocephalus (NPH)
- Fazekas of 3 or higher
- Morbus Huntington
- Parkinson's disease
- HIV/AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoflumilastAlso: EU: Daxas, US: Daliresp, PDE4 inhibitorchronic intervention (24 weeks): roflumilast capsule | Drug | Roflumilast 100ug, Roflumilast 50ug |
| Placebo oral tabletAlso: PlaceboPill with inactive ingredients to mimic same appearance of roflumilast capsule | Drug | Placebo |
Primary outcome
Verbal Learning Test (VLT) (15 words)
Time frame: Change from baseline to 24 weeks of chronic intake
11 secondary outcomes
Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)
Time frame: Change from baseline to 24 weeks of chronic intake
Mini Mental State Examination (MMSE)
Time frame: Change from baseline to 24 weeks of chronic intake
Pattern Separation Task
Time frame: Change from baseline to 24 weeks of chronic intake
Trail-Making Test (TMT)
Time frame: Change from baseline to 24 weeks of chronic intake
Letter Digit Substitution Test (LDST)
Time frame: Change from baseline to 24 weeks of chronic intake
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline to 24 weeks of chronic intake
Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale
Time frame: Change from baseline to 24 weeks of chronic intake
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline to 24 weeks of chronic intake
QoL-AD
Time frame: Change from baseline to 24 weeks of chronic intake
EuroQol
Time frame: Change from baseline to 24 weeks of chronic intake
Boston Naming Task
Time frame: Change from baseline to 24 weeks of chronic intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 38438923Possemis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inez Ramakers, Dr. contact
Inez Ramakers, Dr. principal investigator
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.
Frans Verhey, Prof. Dr. study director
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands
Arjan Blokland, Prof. Dr. principal investigator
Neuropsychology & Psychopharmacology, FPN, Maastricht University, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast in people with Mild Cognitive Impairment and Mild Dementia, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Possemis, MSc. (+31 (0)43 388 1022, n.possemis@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Learning Test (VLT) (15 words) (time frame: Change from baseline to 24 weeks of chronic intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04658654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.