NCT01421056CompletedPhase 2
A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 74
- Locations
- 6
- Primary Endpoint
- Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
- •Mini-Mental State Examination score higher than 24 at screening.
- •MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
Exclusion Criteria
- •Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
- •Any medical condition that could explain the patients cognitive deficits.
- •CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
- •MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
- •Geriatric Depression Scale (30-point scale) score > 9 at screening.
- •History of stroke.
- •Modified Hachinski ischemic scale score > 4 at screening.
- •Women of childbearing potential.
- •Vitamin B12 or folate deficiency.
- •Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
- •Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
- •Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
- •Concomitant use of memantine at dose > 20 mg/day.
- •Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Arms & Interventions
CHF 5074 1x
Experimental
oral tablet, multidose
Intervention: CHF 5074 1x (Drug)
CHF 5074 2x
Experimental
oral tablet, multidose
Intervention: CHF 5074 2x (Drug)
CHF 5074 3x
Experimental
oral tablet, multidose
Intervention: CHF 5074 3x (Drug)
Outcomes
Primary Outcomes
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
Time Frame: 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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