Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients

Sponsor
Maastricht University Medical Center
Study ID
NCT04658654
Phase
PHASE2
Status
Unknown

Conditions

  • Amnestic Mild Cognitive Disorder
  • Mild Cognitive Impairment
  • Mild Dementia

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    chronic intervention (24 weeks): roflumilast capsule
  • Placebo oral tablet — DRUG
    Pill with inactive ingredients to mimic same appearance of roflumilast capsule

Study Details

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.

Key Dates

Start date
Nov 19, 2021
Status verified
Apr 2022
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo oral capsule, once daily for 24 weeks
  • Experimental: Roflumilast 50ug
    Roflumilast (50 microgram) oral capsule, once daily for 24 weeks
  • Experimental: Roflumilast 100ug
    Roflumilast (100 microgram) oral capsule, once daily for 24 weeks

Primary Outcome Measure

Verbal Learning Test (VLT) (15 words) [ Time Frame: Change from baseline to 24 weeks of chronic intake ]

Central Contacts

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