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

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Phase 2

Conditions: Mild Dementia; Amnestic Mild Cognitive Disorder; Mild Cognitive Impairment

Treatments: Drug: Roflumilast; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04658654

72476

Details and patient eligibility

About

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo oral capsule, once daily for 24 weeks

Treatment:

Drug: Placebo oral tablet

Roflumilast 50ug

Experimental group

Description:

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

Treatment:

Drug: Roflumilast

Roflumilast 100ug

Experimental group

Description:

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

Treatment:

Drug: Roflumilast