Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04854811 |
Other study ID # |
NL74897.068.20 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
July 7, 2021 |
Est. completion date |
December 1, 2023 |
Study information
Verified date |
January 2024 |
Source |
Maastricht University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of the current project is to validate the effects of chronic rolflumilast treatment
(12 weeks) on cognitive functions (i.e. episodic memory) by means of behavioral tasks, in
people suffering from cognitive impairments at least 1 year after stroke. Secondarily, the
effects of roflumilast on daily activities and well-being will be assessed.
Description:
Rationale: In the Netherlands there are about 400.000 people who suffer from long-term
consequences of a stroke. In the first months, spontaneous neurological recovery can take
place, but there is hardly any functional recovery found one year after a stroke. About 40%
of these patients indicate that one of the greatest problems they are facing is the
impairment in cognitive functions, which also seems to be predictive for the disease outcome.
Currently, the main focus of helping these patients is helping them to cope with and adapt to
the new situation. There is a great medical need to actually improve cognitive functions in
people that still suffer from persistent cognitive impairments one year after a stroke.
Animal studies have shown that the enzyme phosphodiesterase type 4 (PDE4) plays an important
role in the brain, as it has been shown to be critically linked to neuronal plasticity.
Although animal studies may not always predict effects in humans, there is a strong case that
PDE4 inhibition may also work in humans. Researchers from Maastricht University, and others,
have shown that the PDE4 inhibitor roflumilast improved memory performance in old healthy
participants and in schizophrenic patients. This is a proof of concept that PDE4 inhibition
can improve memory performance in humans. A logical next step is to test if roflumilast can
improve cognitive functioning and daily life activities in people suffering from cognitive
problems more than one year after stroke.
Objective: The objective is to validate the effects of chronic roflumilast treatment on
cognitive function (i.e. episodic memory) by means of behavioral tasks, in people suffering
from cognitive impairments at least 1 year after stroke. Secondary, the effects of
roflumilast on daily activities and well-being will be assessed.
Study design: The first phase of study will be conducted according to a double-blind,
randomized placebo-controlled, between-subjects design. In a second phase, the placebo group
will be given the opportunity to receive roflumilast. This is an open label design.
Study population: 100 female and male, people (41-70 years old) suffering from cognitive
complaints 1 year after stroke will be recruited via advertisements via social media and via
local caretaking organizations (e.g., SGL, Adelante).
Intervention: The study will consist of 2 arms (N = 50 per arm): placebo and 100 μg
roflumilast. The duration of treatment is planned for 3 months and participants will be
tested at baseline, after 1.5 months, after 3 months. The participants will also do daily
computer games to stimulate their brain function. The roflumilast group will be tested 3
months treatment stopped to test if the effects last after treatment is discontinued. After
the end of the 3 months-intervention period, the participants of the placebo group will be
identified and they will be asked whether they would like to take roflumilast for a 3-month
period. This will give information as to the roflumilast effects in an open label setting.
Moreover, this gives the participants in the placebo group the opportunity to receive the
active treatment (if they wish)."