Cognitive Effects of Roflumilast in MCI Patients

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the current project is to validate whether chronic intake (24 weeks) roflumilast (PDE4 inhibitor) can improve cognition in clinical patients with mild cognitive impairment (MCI). The project will demonstrate whether episodic memory, but also attention, information processing or executive function improves with chronic administration of roflumilast in MCI patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Treatments: Phosphodiesterase 4 Inhibitors

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 30

• MMSE of 20 or higher

• MCI due to AD diagnosis

• Memory performance on the delayed recall in the clinically relevant 15 words VLT has to be 1-2 SD below the average, as well as increased cerebrospinal fluid (CSF) Ab marker and/or a positive biomarker of neuronal injury (MRI scan including measurements of decreased hippocampal volume or medial temporal atrophy by volumetric measures or visual rating)

Exclusion Criteria:

• Normal Pressure Hydrocephalus (NPH)

• 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) and asthma

• History of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime)

• 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) centrally acting beta-blockers, 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