Evaluation of safety & tolerability of multiple dose regimens of CHF 5074 and exploration of effects on potential markers of clinical efficacy in patients with mild cognitive impairment (CT04) (clinicaltrials.gov) - May 17, 2012 - P2, N=96; Active, not recruiting -> Completed; Completion date: May 2012 -> Apr 2012
Completion date • Trial completion • Alzheimer's Disease
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This study has been completed.
First Received on February 23, 2011. Last Updated on May 17, 2012 History of Changes Sponsor: Chiesi Pharmaceuticals Inc.
Information provided by (Responsible Party): Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01303744
Purpose
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.
Condition
Alzheimer's Disease
Intervention
Drug: CHF 5074 1x
Drug: CHF 5074 2x
Drug: CHF 5074 3x
Drug: Placebo
Phase
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Resource links provided by NLM:
MedlinePlus related topics: Alzheimer's Disease Mild Cognitive Impairment
U.S. FDA Resources
Further study details as provided by Chiesi Pharmaceuticals Inc.:
Primary Outcome Measures:
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Measurement of trough CHF 5074 plasma levels [ Time Frame: Days 29, 57 and 85 ] [ Designated as safety issue: No ]
Enrollment: 96
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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