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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: CHF 5074 1x
Drug: CHF 5074 2x
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiesi Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF 5074 1x
oral tablet, multidose
 Drug: CHF 5074 1x
oral tablet, 1x, once a day for 24 months
Experimental: CHF 5074 2x
oral tablet, multidose
 Drug: CHF 5074 2x
oral tablet, 2x, once a day for 24 months
Placebo Comparator: Placebo
placebo, oral tablet, multidose
 Drug: Placebo
oral tablet,once a day for 24 months

  Eligibility

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723670

Sponsors and Collaborators
Chiesi Pharmaceuticals Inc.
Investigators
Principal Investigator: Joel S Ross, MD Memory Enhancement Center of America
  More Information

No publications provided

Responsible Party: Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01723670     History of Changes
Other Study ID Numbers: CCD-1109-PR-0072
Study First Received: October 31, 2012
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Nerve Degeneration
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013