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)

January 7, 2014 updated by: Chiesi Farmaceutici S.p.A.

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

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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Castellanza, Italy
        • Clinica Santa Maria, Div Neurologia
      • Milano, Italy
        • Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Memory Enhancement Center of America, Inc.
      • Monroe Twp, New Jersey, United States, 08831
        • Memory Center of New Jersey, Inc.
      • Toms River, New Jersey, United States, 08755
        • Memory Enhancement Center of NJ, Inc.
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHF 5074 1x
oral tablet, multidose
oral tablet, 1x, once a day in the morning for 24 weeks
Experimental: CHF 5074 2x
oral tablet, multidose
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
Experimental: CHF 5074 3x
oral tablet, multidose
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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