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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)

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ClinicalTrials.gov Identifier: NCT01723670
Recruitment Status : Withdrawn
First Posted : November 8, 2012
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
CERESPIR

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CHF 5074 1x Drug: CHF 5074 2x Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To determine the effects on change from baseline on brain atrophy [ Time Frame: pre-dose, Months 6, 12, 18, 24 and Washout ]

Secondary Outcome Measures :
  1. To determine the presence of other biomarkers of neuronal degeneration [ Time Frame: Day 1 ]
  2. To determine the presence of other biomarkers of neuronal degeneration [ Time Frame: Month 24 ]

Other Outcome Measures:
  1. Change from baseline in cognitive performance [ Time Frame: pre-dose, Month 6, Month 12, Month18, Month 24 ]
    rate of cognitive decline

  2. Change from baseline in global clinical status [ Time Frame: pre-dose, Month 6, Month 12, Month 18, Month 24 ]


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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723670


Sponsors and Collaborators
CERESPIR
Investigators
Principal Investigator: Joel S Ross, MD Memory Enhancement Center of America

Responsible Party: CERESPIR
ClinicalTrials.gov Identifier: NCT01723670     History of Changes
Other Study ID Numbers: CCD-1109-PR-0072
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

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