ROMEMA

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

Conditions

Prodromal/Mild Cognitive Impairment due to Alzheimer’s disease

Mild Alzheimer's dementia

Sponsor

Maastricht University Medical Center

Clinical Trial

Phase II

Status

Currently recruiting

Drug

Roflumilast

Countries

Netherlands

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.