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

NCT ID: NCT04658654

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-19
• Study Completion Date: 2023-10-31

Brief 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

Mild Cognitive Impairment; Mild Dementia; Amnestic Mild Cognitive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo oral capsule, once daily for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Pill with inactive ingredients to mimic same appearance of roflumilast capsule

Roflumilast 50ug

Roflumilast (50 microgram) oral capsule, once daily for 24 weeks

Group Type: EXPERIMENTAL

Roflumilast

Intervention Type: DRUG

chronic intervention (24 weeks): roflumilast capsule

Roflumilast 100ug

Roflumilast (100 microgram) oral capsule, once daily for 24 weeks

Group Type: EXPERIMENTAL

Roflumilast

Intervention Type: DRUG

chronic intervention (24 weeks): roflumilast capsule

Interventions

Roflumilast

chronic intervention (24 weeks): roflumilast capsule

Intervention Type: DRUG

Placebo oral tablet

Pill with inactive ingredients to mimic same appearance of roflumilast capsule

Intervention Type: DRUG

Other Intervention Names

EU: Daxas; US: Daliresp; PDE4 inhibitor; Placebo

Eligibility Criteria

Inclusion Criteria

• 50 to 90 years of age
• Willingness (including the informal caregiver) to sign an informed consent
• Body mass index (BMI) between 18.5 and 35
• MMSE of 20 or higher
• Clinical (amnestic)MCI or mild dementia diagnosis
• Memory performance on the delayed recall in the clinically relevant 15 words VLT of 1 or more SD below the average
• Clinical dementia rating (CDR) scale total score of 0.5 or 1
• Fazekas of 2 or lower

Exclusion Criteria

• Normal Pressure Hydrocephalus (NPH)
• Fazekas of 3 or higher
• Morbus Huntington
• Parkinson's disease
• HIV/AIDS
• Hepatitis C & B
• Recent Transient Ischemic Attack (TIA) (< 2 years)
• Cerebrovascular Accident (CVA) (< 2 years)
• TIA/CVA followed by cognitive decline (within 3 months)
• Chronic Obstructive Pulmonary Disease (COPD) gold criteria 3 or 4 and severe asthma
• History of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime)
• Current radiotherapy
• Current affective disorder (i.e. anxiety or major depression)
• Cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation.
• Current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, MDMA and cocaine
• Patients with moderate or major liver impairments will be excluded (e.g. Child-Pugh B and C).
• Use of medication showing strong inhibition of either CYP3A4 or CYP1A2
• Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Patients participating in other drug studies
• If patient does not have the possibility to be accompanied by the same informal caregiver during all test days

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inez Ramakers, Dr.

Role: PRINCIPAL_INVESTIGATOR

Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.

Frans Verhey, Prof. Dr.

Role: STUDY_DIRECTOR

Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands

Arjan Blokland, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Neuropsychology & Psychopharmacology, FPN, Maastricht University, The Netherlands

Jos Prickaerts, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.

Locations

University of Maastricht, Faculty of Psychology and Neuropsychology

Maastricht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Nina Possemis, MSc.

Role: CONTACT

n.possemis@maastrichtuniversity.nl

+31 (0)43 388 1022

Inez Ramakers, Dr.

Role: CONTACT

i.ramakers@maastrichtuniversity.nl

Facility Contacts

Nina Possemis, MSc

Role: primary

n.possemis@maastrichtuniveristy.nl

References

Possemis N, Verhey F, Prickaerts J, Blokland A, Ramakers I. A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer's disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial. Trials. 2024 Mar 4;25(1):162. doi: 10.1186/s13063-024-08001-3.

Reference Type: DERIVED

PMID: 38438923 (View on PubMed)

Other Identifiers

72476

Identifier Type: -

Identifier Source: org_study_id