NCT04658654UnknownPhase 2
A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia
Maastricht University Medical Center1 site in 1 country81 target enrollmentStarted: November 19, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Verbal Learning Test (VLT) (15 words)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Placebo
Placebo Comparator
Placebo oral capsule, once daily for 24 weeks
Intervention: Placebo oral tablet (Drug)
Roflumilast 50ug
Experimental
Roflumilast (50 microgram) oral capsule, once daily for 24 weeks
Intervention: Roflumilast (Drug)
Roflumilast 100ug
Experimental
Roflumilast (100 microgram) oral capsule, once daily for 24 weeks
Intervention: Roflumilast (Drug)
Outcomes
Primary Outcomes
Verbal Learning Test (VLT) (15 words)
Time Frame: Change from baseline to 24 weeks of chronic intake
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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