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

Primary Purpose

Mild Cognitive Impairment, Mild Dementia, Amnestic Mild Cognitive Disorder

Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Roflumilast
Placebo oral tablet
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring MCI, amnestic MCI, mild dementia

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maastricht, Faculty of Psychology and NeuropsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Roflumilast 50ug

Roflumilast 100ug

Arm Description

Placebo oral capsule, once daily for 24 weeks

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

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

Outcomes

Primary Outcome Measures

Verbal Learning Test (VLT) (15 words)

Secondary Outcome Measures

Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)
Mini Mental State Examination (MMSE)
Pattern Separation Task
Trail-Making Test (TMT)
Letter Digit Substitution Test (LDST)
Hospital Anxiety and Depression Scale (HADS)
Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale
Neuropsychiatric Inventory (NPI)
QoL-AD
EuroQol
Boston Naming Task

Full Information

First Posted
August 31, 2020
Last Updated
April 13, 2022
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04658654
Brief Title
Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients
Acronym
ROMEMA
Official Title
A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Mild Dementia, Amnestic Mild Cognitive Disorder
Keywords
MCI, amnestic MCI, mild dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsule, once daily for 24 weeks
Arm Title
Roflumilast 50ug
Arm Type
Experimental
Arm Description
Roflumilast (50 microgram) oral capsule, once daily for 24 weeks
Arm Title
Roflumilast 100ug
Arm Type
Experimental
Arm Description
Roflumilast (100 microgram) oral capsule, once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Other Intervention Name(s)
EU: Daxas, US: Daliresp, PDE4 inhibitor
Intervention Description
chronic intervention (24 weeks): roflumilast capsule
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Pill with inactive ingredients to mimic same appearance of roflumilast capsule
Primary Outcome Measure Information:
Title
Verbal Learning Test (VLT) (15 words)
Time Frame
Change from baseline to 24 weeks of chronic intake
Secondary Outcome Measure Information:
Title
Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Mini Mental State Examination (MMSE)
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Pattern Separation Task
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Trail-Making Test (TMT)
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Letter Digit Substitution Test (LDST)
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Neuropsychiatric Inventory (NPI)
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
QoL-AD
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
EuroQol
Time Frame
Change from baseline to 24 weeks of chronic intake
Title
Boston Naming Task
Time Frame
Change from baseline to 24 weeks of chronic intake
Other Pre-specified Outcome Measures:
Title
Conversion to Alzheimer's disease (AD)
Time Frame
24 weeks
Title
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
Title
Tau in tears
Time Frame
Change from baseline to 24 weeks of chronic intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Possemis, MSc.
Phone
+31 (0)43 388 1022
Email
n.possemis@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Inez Ramakers, Dr.
Email
i.ramakers@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inez Ramakers, Dr.
Organizational Affiliation
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frans Verhey, Prof. Dr.
Organizational Affiliation
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arjan Blokland, Prof. Dr.
Organizational Affiliation
Neuropsychology & Psychopharmacology, FPN, Maastricht University, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jos Prickaerts, Prof. Dr.
Organizational Affiliation
Psychiatry and Neuropsychology, FHML, Maastricht University, the Netherlands.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maastricht, Faculty of Psychology and Neuropsychology
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Possemis, MSc
Email
n.possemis@maastrichtuniveristy.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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

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