memory impairment mild memory impairment sub-clinical cognitive deficits
Conditions
Interventions
Subjects will be treated 4 times with Roflumilast 100µg, 250µg, 1000µg and a
placebo. The treatment order will be established by counterbalancing.
Sponsors
Takeda
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subject, aged 60 to 80 years, inclusive, at the time of informed consent. 2. Memory performance between 1 to 2 SD below (for Impaired Elderly) and between 0.5 SD below and 0.5 SD above (for Healthy Elderly) aged, gender, and education level corrected normative values assessed using the VLT.;For a complete list of all inclusion criteria, please see protocol page 34.
Exclusion criteria
Exclusion criteria: 1. Subjects with previous or existing major psychiatric symptoms. 2. Subjects received any investigational compound within 30 days prior to the study. 3 Subjects received Roflumilast in a previous study or as therapeutic agent. For a complete list of all exclusion criteria, please see protocol page 34/35.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: 1. VLT outcome scores captured as number of recalled items both in the immediate (ie, first, second, third, and total) and in the two delayed tests as well as captured as correct answers in the recognition part of the VLT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. Amplitude and latency of ERP*s assessed during memorization phase of the VLT (ie, P300, N400, and P600). 2. SMT (Spatial memory task) outcome scores captured as the number of correctly localized items in the immediate and in the 2 delayed recalls and the recognition test. 3. EEG measurements captured as the amplitude and latency of ERP*s (ie, P300, N400, and P600) during the SMT. 4. Stroop task outcome scores captured as both the number of errors and reaction time and the amplitude and latency of ERP*s (ie, N200 and P300). 5. EEG measurements captured as Mismatch Negativity (MMN) and P3a amplitude and latency during the Novelty oddball task. 6. EEG measurements captured as S2/S1 ratio and S1-S2 difference score of the P50 amplitude at sensory gating paradigm. 7. Cognitive improvement as captured by BL-VAS (Bond-Lader Visual Analogue Scales). 8. Cmax and AUC of roflumilast and roflumilast N-oxide. Safety assessments: 1. Physical examination findings. 2. Vital signs. 3. 12-lead electrocardiogram (ECG) findings. 4. Clinical laboratory evaluations including hematology, chemistry and urinalysis. 5. Treatment emergent adverse events (TEAEs). | — |
Countries
Netherlands
Outcome results
None listed