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ROMEMA

Cognitive Effects of Roflumilast in (Amnestic) Mild Cognitive Impairment and Mild Dementia Patients (ROMEMA)

Sponsor
Maastricht University Medical Center
Phase
Drug
Roflumilast
Countries

Information about the drug that will be tested in the study

Administration

One capsule taken orally once daily

Is the drug already on the market for another medical condition?

Yes – for the treatment of inflammatory conditions of the lungs such as chronic obstructive pulmonary disease (COPD)

Will all participants receive the same drug?

Participants will be selected at random to either receive one of the following options:

  • One capsule of Roflumilast (50 µg)
  • One capsule of Roflumilast (100 µg)
  • One placebo capsule (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect) administered twice daily.

Neither the participant nor the investigators will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of this study is to validate whether chronic intake roflumilast can improve cognition in people with (amnestic) mild cognitive impairment (MCI) and in people with mild dementia.

How long will the treatment last?

24 weeks (6 months)

What your involvement will entail?
  • During the study, participants and their study partner will be asked to complete some questionnaires and tasks to evaluate their cognition, behaviour, well-being, function and activities of daily living (e.g. VLT, ADAS-Cog, MMSE, ADCS-ADL, NPI)
  • Participants will also be asked to do some blood tests.

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be between 50 and 90 years old
  • Sign an informed consent
  • Have a body mass index (BMI) between 18.5 and 35
  • Have a score of 20 or higher in the MMSE questionnaire (a short test about your memory) and a score of 0.5 or 1 in the Clinical Dementia Rating Score (CDR). This would suggest that the person has an impairment in their memory that is at a mild stage
     
  • Have a diagnosis of clinical (amnestic) mild cognitive impairment or mild dementia
     
  • Have a study partner who has a sufficient contact with the participant, and is willing to participate in study procedures throughout the study duration.
     
Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

  • Other degenerative dementia such as Morbus Huntington or Parkinson's disease
  • A disease or conditions that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. psychiatric symptoms, auto-immune disease, inflammatory neurological disorders)
  • Participants must not have history of HIV, Hepatitis B or C or severe asthma
     
  • Drug or alcohol abuse or dependence
     
  • History of liver impairments, recent cerebrovascular accident, recent Transient Ischemic Attack (TIA)
     
  • Participation in other drug studies.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

Clinicaltrials.gov identifier

NCT04658654

Study contact information

Nina Possemis +31 (0)43 388 1022

  n.possemis@maastrichtuniversity.nl

Inez Ramakers

  i.ramakers@maastrichtuniversity.nl

Link to full text

https://clinicaltrials.gov/ct2/show/NCT04658654

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on June 2022.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

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