Trial record 7 of 7 for: CHF 5074

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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Chiesi Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT01723670

First received: October 31, 2012

Last updated: November 20, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2012

Last Updated Date

November 20, 2012

Start Date ^ICMJE

December 2012

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the effects on change from baseline on brain atrophy [ Time Frame: pre-dose, Months 6, 12, 18, 24 and Washout ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01723670 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the presence of other biomarkers of neuronal degeneration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
To determine the presence of other biomarkers of neuronal degeneration [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Change from baseline in cognitive performance [ Time Frame: pre-dose, Month 6, Month 12, Month18, Month 24 ] [ Designated as safety issue: No ]
rate of cognitive decline
Change from baseline in global clinical status [ Time Frame: pre-dose, Month 6, Month 12, Month 18, Month 24 ] [ Designated as safety issue: No ]

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: CHF 5074 1x
oral tablet, 1x, once a day for 24 months
Drug: CHF 5074 2x
oral tablet, 2x, once a day for 24 months
Drug: Placebo
oral tablet,once a day for 24 months

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
Placebo Comparator: Placebo
placebo, oral tablet, multidose

Intervention: Drug: Placebo

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

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

March 2016

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

45 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01723670

Other Study ID Numbers ^ICMJE

CCD-1109-PR-0072

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

Information Provided By

Chiesi Pharmaceuticals Inc.

Verification Date

November 2012

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

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