Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment (CT05)

February 9, 2015 updated by: CERESPIR

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • Phase 2

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

45 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
  • Diagnosis of amnestic Mild Cognitive Impairment.
  • Mini-Mental State Examination score higher than 24 at screening.

Exclusion Criteria:

  • Diagnosis of Alzheimer's disease.
  • Any medical condition that could explain the subject's cognitive deficits.
  • MRI scans having evidence of pre-specified brain abnormalities.
  • History of stroke.
  • Vitamin B12 or folate deficiency.
  • Skin cancers and any cancer that is being actively treated.
  • Diagnosis of schizophrenia or recurrent mood disorder.
  • Abnormal kidney function.
  • Concomitant use of any study prohibitive medication.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHF 5074 1x
oral tablet, multidose
oral tablet, 1x, once a day for 24 months
Experimental: CHF 5074 2x
oral tablet, multidose
oral tablet, 2x, once a day for 24 months
Placebo Comparator: Placebo
placebo, oral tablet, multidose
oral tablet,once a day for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effects on change from baseline on brain atrophy
Time Frame: pre-dose, Months 6, 12, 18, 24 and Washout
pre-dose, Months 6, 12, 18, 24 and Washout

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the presence of other biomarkers of neuronal degeneration
Time Frame: Day 1
Day 1
To determine the presence of other biomarkers of neuronal degeneration
Time Frame: Month 24
Month 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in cognitive performance
Time Frame: pre-dose, Month 6, Month 12, Month18, Month 24
rate of cognitive decline
pre-dose, Month 6, Month 12, Month18, Month 24
Change from baseline in global clinical status
Time Frame: pre-dose, Month 6, Month 12, Month 18, Month 24
pre-dose, Month 6, Month 12, Month 18, Month 24

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Joel S Ross, MD, Memory Enhancement Center of America

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

December 1, 2012

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 8, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

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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