Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
CERESPIR Identifier:
First received: October 31, 2012
Last updated: February 9, 2015
Last verified: February 2015

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:

Further study details as provided by CERESPIR:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01723670

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

No publications provided

Responsible Party: CERESPIR Identifier: NCT01723670     History of Changes
Other Study ID Numbers: CCD-1109-PR-0072
Study First Received: October 31, 2012
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Nerve Degeneration
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Tauopathies processed this record on February 26, 2015