Trials / Unknown
UnknownNCT04658654
Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients
A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- Sponsor
- Maastricht University Medical Center · Academic / Other
- Sex
- All
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast | chronic intervention (24 weeks): roflumilast capsule |
| DRUG | Placebo oral tablet | Pill with inactive ingredients to mimic same appearance of roflumilast capsule |
Timeline
- Start date
- 2021-11-19
- Primary completion
- 2023-10-01
- Completion
- 2023-10-01
- First posted
- 2020-12-08
- Last updated
- 2022-04-21
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04658654. Inclusion in this directory is not an endorsement.