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Status unknownNCT04658654ROMEMAUpdated Apr 21, 2022

Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients

A Phase 2 interventional study of Roflumilast and Placebo oral tablet in Mild Cognitive Impairment, Mild Dementia and Amnestic Mild Cognitive Disorder, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Maastricht University Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mild Cognitive Impairment
  • Mild Dementia
  • Amnestic Mild Cognitive Disorder

Keywords

  • MCI, amnestic MCI, mild dementia
03

In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's planned enrollment of 81 is above the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.

Browse Maastricht University Medical Center studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
81 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo oral capsule, once daily for 24 weeks

    Drug: Placebo oral tablet

  • Experimental
    Roflumilast 50ug

    Roflumilast (50 microgram) oral capsule, once daily for 24 weeks

    Drug: Roflumilast

  • Experimental
    Roflumilast 100ug

    Roflumilast (100 microgram) oral capsule, once daily for 24 weeks

    Drug: Roflumilast

Interventions

  • DrugRoflumilast

    chronic intervention (24 weeks): roflumilast capsule

    Also known as: EU: Daxas, US: Daliresp, PDE4 inhibitor

  • DrugPlacebo oral tablet

    Pill with inactive ingredients to mimic same appearance of roflumilast capsule

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Verbal Learning Test (VLT) (15 words)

    Time frame: Change from baseline to 24 weeks of chronic intake

Secondary outcomes

  1. Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)

    Time frame: Change from baseline to 24 weeks of chronic intake

  2. Mini Mental State Examination (MMSE)

    Time frame: Change from baseline to 24 weeks of chronic intake

  3. Pattern Separation Task

    Time frame: Change from baseline to 24 weeks of chronic intake

  4. Trail-Making Test (TMT)

    Time frame: Change from baseline to 24 weeks of chronic intake

  5. Letter Digit Substitution Test (LDST)

    Time frame: Change from baseline to 24 weeks of chronic intake

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from baseline to 24 weeks of chronic intake

  7. Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale

    Time frame: Change from baseline to 24 weeks of chronic intake

  8. Neuropsychiatric Inventory (NPI)

    Time frame: Change from baseline to 24 weeks of chronic intake

  9. QoL-AD

    Time frame: Change from baseline to 24 weeks of chronic intake

  10. EuroQol

    Time frame: Change from baseline to 24 weeks of chronic intake

  11. Boston Naming Task

    Time frame: Change from baseline to 24 weeks of chronic intake

Other outcomes

  1. Conversion to Alzheimer's disease (AD)

    Time frame: 24 weeks

  2. Pharmacokinetic validation of roflumilast and its active metabolite roflumilast N-Oxide in plasma

    Time frame: Acute, 12 weeks chronic intake and 24 weeks chronic intake

  3. Tau in tears

    Time frame: Change from baseline to 24 weeks of chronic intake

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Oct 2023, 23 months after the start.

Of 144 non-industry phase 2 interventional studies under Cognitive Dysfunction, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 67. This study's planned 23 months is below that.

Counting every sponsor, half of 183 studies reached it within 44 months; a quarter within 22 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2020
First posted
Dec 8, 2020
StartActual
Nov 19, 2021
Primary completionEst.
Oct 2023
CompletionEst.
Oct 2023
Last update
Apr 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04658654
Lead sponsor
Maastricht University Medical Center
Responsible party
Sponsor
First posted
Dec 8, 2020
Start date
Nov 19, 2021
Primary completion
Oct 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
Apr 21, 2022

Study contacts

Nina Possemis, MSc.
Contact
n.possemis@maastrichtuniversity.nl
+31 (0)43 388 1022
Inez Ramakers, Dr.
Contact
i.ramakers@maastrichtuniversity.nl
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
Jos Prickaerts, Prof. Dr.
principal investigator · Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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