This research is being conducted by Maastricht University (UM). This study is funded by ZonMw, the Dutch organization for health research and care innovation. The pharmaceutical industry has no role in the funding of this study. For this study, 81 subjects with mild memory and/or concentration complaints and their informal caregivers are needed. The medical ethical review board of Maastricht University Hospital and Maastricht University (METC aZM/UM) has approved this study. General information on participating in such research can be found on the website of the Government: www.rijksoverheid.nl/mensenonderzoek. Are you interested in the scientific background of this study? Then click here.
The aim of the study is to investigate the efficacy of the drug roflumilast for the treatment of mild cognitive impairment (MCI). We are comparing the efficacy of roflumilast with that of a placebo. A placebo is a drug without an active ingredient, a “fake” drug. With an increasingly aging population, more and more people are having problems with their memory, attention, language or learning ability: known as cognition for short. The possibilities of treating people with these complaints are limited. For this reason we are looking for ways to reduce these symptoms by treating them with a drug. In this study we will investigate in people with mild memory problems whether a 6-month treatment with roflumilast improves memory and attention. Furthermore, we are also interested in the views of the patient’s informal caregiver.
Roflumilast is a phosphodiesterase 4 inhibitor (PDE4) with anti-inflammatory activity. PDE4 belongs to a family of enzymes that specifically catalyzes the hydrolysis of cyclic adenosine monophosphate (cAMP). PDE4 inhibitors cause an increase in intracellular cAMP and an activation of protein kinase A. The subsequent phosphorylation and inactivation of transcription factors results in a decrease in the inflammatory process. A single administration of roflumilast may result in an increase in both the neurotransmitter glutamate and its (AMPA) receptors. With chronic administration, roflumilast may also lead to more synapses, spurs and neurons. This may offer protection against the toxic proteins Abeta (plaques) and tau (tangles).
The treatment in this study lasts 24 weeks (6 months). This is to be able to determine if the drug roflumilast is really effective in people with memory complaints. There are 3 treatment groups in this study, group 1; placebo, group 2; roflumilast (Daxas®) 50 micrograms, and group 3: roflumilast (Daxas®) 100 micrograms. There are 27 subjects in each group. A random draw determines which group the subject will be in. The study is double-blind, meaning that neither the principal investigator nor the subject himself knows which group the subject belongs to during the study. For 24 weeks, 1 capsule is taken daily after dinner.
As part of the study, it is necessary to obtain information from the participant’s informal caregiver. We will ask him/her to complete two additional questionnaires. In these questionnaires, we will ask the informal caregiver to estimate the participant’s memory complaints and how they affect the participant’s daily functioning. Questions about mood and quality of life will also be asked.
Information about this study is also included in an overview of medical-scientific studies namely www.clinicaltrials.gov and www.trialsregister.nl. These do not contain any data that can be traced back to you. After the study, these websites will show a summary of the results of this study. You can find this study HERE en HERE.