A randomized, double-blind, placebo controlled, four-period, cross-over study to evaluate the cognitive effects of single oral administration of roflumilast in aging-related memory impairment
Completed
- Conditions
- memory impairmentmild memory impairmentsub-clinical cognitive deficits
- Registration Number
- NL-OMON40236
- Lead Sponsor
- Takeda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>1. VLT outcome scores captured as number of recalled items both in the<br /><br>immediate (ie, first, second, third, and total) and in the two delayed tests as<br /><br>well as captured as correct answers in the recognition part of the VLT.</p><br>
- Secondary Outcome Measures
Name Time Method