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

April 13, 2022 updated by: Maastricht University Medical Center

A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Placebo oral capsule, once daily for 24 weeks
Drug: Placebo oral tablet
Pill with inactive ingredients to mimic same appearance of roflumilast capsule
Other Names:
  • Placebo
EXPERIMENTAL: Roflumilast 50ug
Roflumilast (50 microgram) oral capsule, once daily for 24 weeks
Drug: Roflumilast
chronic intervention (24 weeks): roflumilast capsule
Other Names:
  • EU: Daxas
  • US: Daliresp
  • PDE4 inhibitor
EXPERIMENTAL: Roflumilast 100ug
Roflumilast (100 microgram) oral capsule, once daily for 24 weeks
Drug: Roflumilast
chronic intervention (24 weeks): roflumilast capsule
Other Names:
  • EU: Daxas
  • US: Daliresp
  • PDE4 inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Verbal Learning Test (VLT) (15 words)
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Mini Mental State Examination (MMSE)
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Pattern Separation Task
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Trail-Making Test (TMT)
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Letter Digit Substitution Test (LDST)
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Neuropsychiatric Inventory (NPI)
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
QoL-AD
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
EuroQol
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake
Boston Naming Task
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Conversion to Alzheimer's disease (AD)
Time Frame: 24 weeks
24 weeks
Pharmacokinetic validation of roflumilast and its active metabolite roflumilast N-Oxide in plasma
Time Frame: Acute, 12 weeks chronic intake and 24 weeks chronic intake
Acute, 12 weeks chronic intake and 24 weeks chronic intake
Tau in tears
Time Frame: Change from baseline to 24 weeks of chronic intake
Change from baseline to 24 weeks of chronic intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 72476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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