Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 7 of 7 for:    CHF 5074

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This study has been withdrawn prior to enrollment.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

October 31, 2012
November 20, 2012
December 2012
March 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01723670 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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 ]
Same as current
 
Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Alzheimer's Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
45 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01723670
CCD-1109-PR-0072
Yes
Chiesi Pharmaceuticals Inc.
Chiesi Pharmaceuticals Inc.
Not Provided
Principal Investigator: Joel S Ross, MD Memory Enhancement Center of America
Chiesi Pharmaceuticals Inc.
November 2012

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