ROMEMA

UnknownPhase 2

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

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

Lead sponsor

Maastricht University Medical Center

Asset

Roflumilast

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Mixed / unspecified dementia

Key I/E criterion

•MMSE 20

Primary endpoint

•Verbal Learning Test (VLT) (15 words)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID72476

NCT IDNCT04658654

Timeline

Milestones

Study first posted2020-12-08actual

Study start2021-11-19actual

Last update posted2022-04-21actual

Primary completion2023-10estimated (month precision)

Study completion2023-10estimated (month precision)

Assets

Drug assets

Roflumilast

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Behavior / neuropsychiatric

Executive function / language

Function / daily living

Disease progression

Caregiver / quality of life

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)

Time frame:Change from baseline to 24 weeks of chronic intake

ADAS-Cog

descriptive

Secondary/protocol endpoint

Mini Mental State Examination (MMSE)

Time frame:Change from baseline to 24 weeks of chronic intake

Mini-Mental State Examination (MMSE)

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

Boston Naming Task

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale

Time frame:Change from baseline to 24 weeks of chronic intake

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Hospital Anxiety and Depression Scale (HADS)

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Change from baseline to 24 weeks of chronic intake

Neuropsychiatric Inventory (NPI)

descriptive

Disease progression

1 endpoint

Other/protocol endpoint

Conversion to Alzheimer's disease (AD)

Time frame:24 weeks

time to event, event

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

QoL-AD

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

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

descriptive

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Verbal Learning Test (VLT) (15 words)

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Secondary/protocol endpoint/low confidence

Pattern Separation Task

Time frame:Change from baseline to 24 weeks of chronic intake

ratio, descriptive

Secondary/protocol endpoint/low confidence

Trail-Making Test (TMT)

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Secondary/protocol endpoint/low confidence

Letter Digit Substitution Test (LDST)

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Secondary/protocol endpoint/low confidence

EuroQol

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Other/protocol endpoint/low confidence

Tau in tears

Time frame:Change from baseline to 24 weeks of chronic intake

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID38438923via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.