MCI due to AD
Conditions
Interventions
Participants will be instructed to take one capsule every day for 24 weeks. The capsule can be taken with or without food.
The following dose levels will be used, as well as a placebo that only cont
Sponsors
ZonMw
Eligibility
Inclusion criteria
Inclusion criteria: - MCI due to AD diagnosis (diagnosis not older than 1 year), which includes either increased cerebrospinal fluid (CSF) Abeta marker and/or a positive biomarker of neuronal injury i.e. magnetic resonance imaging (MRI) scan including measurements of decreased hippocampal volume or medial temporal atrophy by volumetric measures or visual rating), and a memory performance on the delayed recall in the 15 words VLT of 1-2 standard deviation(s) (SD) below the average. - BMI between 18.5 and 30 - Age between 50 and 90 years - (The same) informal caregiver for each test day - MMSE of 20 or higher - Willingness (both the participant and informal caregiver) to sign an informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participating in this study: - Participants positive for human immunodeficiency virus (HIV) and Hepatitis B & C - Normal Pressure Hydrocephalus (NPH) - Morbus Huntington - Parkinson's disease - Recent Transient Ischemic Attack (TIA) - Cerebrovascular Accident (CVA) (< 2 years) - TIA/CVA followed by cognitive decline (within 3 months) - COPD, 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, Methylenedioxymethamphetamine (MDMA) and cocaine. - Use of medication showing strong inhibition of either CYP3A4 (e.g. clarithromycin, erythromycin and other antibiotics) or CYP1A2 (e.g. fluvoxamine, ciprofloxacin and other fluoroquinolones) is also an exclusion criterion because of interference with roflumilast metabolism resulting in reduced therapeutic effectiveness of roflumilast. - Individuals with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption will be excluded, as both the placebo and roflumilast contain lactose monohydrate. - Additionally, during the period of the present study, participants are not allowed to participate in other drug trials. - Lastly, if a participant does not have the possibility to be accompanied at every test session by the same informal caregiver (i.e. retraction informed consent) they will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is cognitive performance using a test battery in which episodic memory is the primary outcome measure as assessed with the VLT (15 words), 5 times immediate recall, and a 20 min delayed recall. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary tests include the ADAS-Cog scale (global cognition), MMSE (global cognition), Pattern Separation Memory Task (spatial memory), Letter Digit Substitution Test (information processing speed), Trail Making Test (information processing speed and executive functioning), as well as VLT recognition (verbal episodic memory). Other study parameters include assessment of clinically relevant effects including determination of anxiety and depression by the use of the Hospital Anxiety and Depression Scale (HADS), as well as the Neuropsychiatric Inventory (NPI) to determine neuropsychiatric symptoms. The EuroQoL scale and the Qol_AD will be included to measure quality of life. The Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale MCI (ADCS ADL-MCI) scale assesses the competence of the patients in basic and instrumental activities of daily living. The possible conversion to AD dementia (yes/no) will be considered as well, as will tau amount measurement in tears. | — |
Contacts
Public ContactNina Possemis
University of Maastricht
Outcome results
None listed