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 - Open Label Extension (CT04 OLEP)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Chiesi Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT01421056

First received: August 5, 2011

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2011

Last Updated Date

February 11, 2013

Start Date ^ICMJE

July 2011

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01421056 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 - Open Label Extension (CT04 OLEP)

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: CHF 5074 1x
oral tablet, 1x, once a day in the morning for 24 weeks
Drug: CHF 5074 2x
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks
Drug: CHF 5074 3x
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 16 weeks

Study Arm (s)

Experimental: CHF 5074 1x
oral tablet, multidose

Intervention: Drug: CHF 5074 1x
Experimental: CHF 5074 2x
oral tablet, multidose

Intervention: Drug: CHF 5074 2x
Experimental: CHF 5074 3x
oral tablet, multidose

Intervention: Drug: CHF 5074 3x

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Italy

Administrative Information

NCT Number ^ICMJE

NCT01421056

Other Study ID Numbers ^ICMJE

CCD-1014-PR-0053 OLEP, 2010-024270-19

Has Data Monitoring Committee

Yes

Responsible Party

Chiesi Pharmaceuticals Inc.

Study Sponsor ^ICMJE

Chiesi Pharmaceuticals Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Joel S. Ross, MD	Memory Enhancement Center of America, Inc.
Principal Investigator:	Gabriella Bottini, Prof.	Osp. Niguarda Ca Granda

Information Provided By

Chiesi Pharmaceuticals Inc.

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top