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

Phase 2

• Conditions: Mild Cognitive Impairment; Mild Dementia; Amnestic Mild Cognitive Disorder
• Interventions: Drug: Roflumilast; Drug: Placebo oral tablet

• Registration Number: NCT04658654
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2021-11-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-21
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 81

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roflumilast 50ug	Roflumilast	Roflumilast (50 microgram) oral capsule, once daily for 24 weeks
Placebo	Placebo oral tablet	Placebo oral capsule, once daily for 24 weeks
Roflumilast 100ug	Roflumilast	Roflumilast (100 microgram) oral capsule, once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Verbal Learning Test (VLT) (15 words)	Change from baseline to 24 weeks of chronic intake

Secondary Outcome Measures

Name	Time	Method
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
Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)	Change from baseline to 24 weeks of chronic intake
Hospital Anxiety and Depression Scale (HADS)	Change from baseline to 24 weeks of chronic intake
Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale	Change from baseline to 24 weeks of chronic intake
Neuropsychiatric Inventory (NPI)	Change from baseline to 24 weeks of chronic intake
QoL-AD	Change from baseline to 24 weeks of chronic intake
EuroQol	Change from baseline to 24 weeks of chronic intake
Boston Naming Task	Change from baseline to 24 weeks of chronic intake

Trial Locations

Locations (1)

University of Maastricht, Faculty of Psychology and Neuropsychology; 🇳🇱 Maastricht, Netherlands