Conditions: Alzheimer's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 96
Healthy volunteers: no

Brief summary:
To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.

Detailed description:

Arms:
arm 1: oral tablet, multidose arm 2: oral tablet, multidose arm 3: oral tablet, multidose arm 4: placebo, oral tablet, multidose

Interventions: intervention 1: CHF 5074 1x intervention 2: CHF 5074 2x intervention 3: CHF 5074 3x intervention 4: Placebo
Intervention descriptions: intervention 1: oral tablet, 1x, once a day in the morning for 12 weeks intervention 2: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks intervention 3: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks intervention 4: oral tablet, once a day in the morning for 12 weeks

Protocol document: