Back to resultsEvaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment (CT05)
Primary Purpose
Alzheimer's Disease
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CHF 5074 1x
CHF 5074 2x
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer's Disease
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CHF 5074 1x
CHF 5074 2x
Placebo
Arm Description
oral tablet, multidose
oral tablet, multidose
placebo, oral tablet, multidose
Outcomes
Primary Outcome Measures
To determine the effects on change from baseline on brain atrophy
Secondary Outcome Measures
To determine the presence of other biomarkers of neuronal degeneration
To determine the presence of other biomarkers of neuronal degeneration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01723670
Brief Title
Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
Acronym
CT05
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 Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Withdrawn
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CERESPIR
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHF 5074 1x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Arm Title
CHF 5074 2x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, oral tablet, multidose
Intervention Type
Drug
Intervention Name(s)
CHF 5074 1x
Intervention Description
oral tablet, 1x, once a day for 24 months
Intervention Type
Drug
Intervention Name(s)
CHF 5074 2x
Intervention Description
oral tablet, 2x, once a day for 24 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet,once a day for 24 months
Primary Outcome Measure Information:
Title
To determine the effects on change from baseline on brain atrophy
Time Frame
pre-dose, Months 6, 12, 18, 24 and Washout
Secondary Outcome Measure Information:
Title
To determine the presence of other biomarkers of neuronal degeneration
Time Frame
Day 1
Title
To determine the presence of other biomarkers of neuronal degeneration
Time Frame
Month 24
Other Pre-specified Outcome Measures:
Title
Change from baseline in cognitive performance
Description
rate of cognitive decline
Time Frame
pre-dose, Month 6, Month 12, Month18, Month 24
Title
Change from baseline in global clinical status
Time Frame
pre-dose, Month 6, Month 12, Month 18, Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel S Ross, MD
Organizational Affiliation
Memory Enhancement Center of America
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
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