Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients
ROMEMA
A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedStudy Start
First participant enrolled
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedApril 21, 2022
April 1, 2022
1.9 years
August 31, 2020
April 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Verbal Learning Test (VLT) (15 words)
Change from baseline to 24 weeks of chronic intake
Secondary Outcomes (11)
Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)
Change from baseline to 24 weeks of chronic intake
Mini Mental State Examination (MMSE)
Change from baseline to 24 weeks of chronic intake
Pattern Separation Task
Change from baseline to 24 weeks of chronic intake
Trail-Making Test (TMT)
Change from baseline to 24 weeks of chronic intake
Letter Digit Substitution Test (LDST)
Change from baseline to 24 weeks of chronic intake
- +6 more secondary outcomes
Other Outcomes (3)
Conversion to Alzheimer's disease (AD)
24 weeks
Pharmacokinetic validation of roflumilast and its active metabolite roflumilast N-Oxide in plasma
Acute, 12 weeks chronic intake and 24 weeks chronic intake
Tau in tears
Change from baseline to 24 weeks of chronic intake
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo oral capsule, once daily for 24 weeks
Roflumilast 50ug
EXPERIMENTALRoflumilast (50 microgram) oral capsule, once daily for 24 weeks
Roflumilast 100ug
EXPERIMENTALRoflumilast (100 microgram) oral capsule, once daily for 24 weeks
Interventions
chronic intervention (24 weeks): roflumilast capsule
Pill with inactive ingredients to mimic same appearance of roflumilast capsule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maastricht, Faculty of Psychology and Neuropsychology
Maastricht, Netherlands
Related Publications (1)
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.
PMID: 38438923DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inez Ramakers, Dr.
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.
- STUDY DIRECTOR
Frans Verhey, Prof. Dr.
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands
- PRINCIPAL INVESTIGATOR
Arjan Blokland, Prof. Dr.
Neuropsychology & Psychopharmacology, FPN, Maastricht University, The Netherlands
- PRINCIPAL INVESTIGATOR
Jos Prickaerts, Prof. Dr.
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
December 8, 2020
Study Start
November 19, 2021
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share