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

NCT04658654 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2022-04-21

No results posted yet for this study

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

DRUG

Roflumilast

chronic intervention (24 weeks): roflumilast capsule

DRUG

Placebo oral tablet

Pill with inactive ingredients to mimic same appearance of roflumilast capsule

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Inez Ramakers, Dr. · Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.

  • Frans Verhey, Prof. Dr. · Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands

  • Arjan Blokland, Prof. Dr. · Neuropsychology & Psychopharmacology, FPN, Maastricht University, The Netherlands

  • Jos Prickaerts, Prof. Dr. · Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658654 on ClinicalTrials.gov