- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723670
Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment (CT05)
February 9, 2015 updated by: CERESPIR
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHF 5074 1x
oral tablet, multidose
|
oral tablet, 1x, once a day for 24 months
|
Experimental: CHF 5074 2x
oral tablet, multidose
|
oral tablet, 2x, once a day for 24 months
|
Placebo Comparator: Placebo
placebo, oral tablet, multidose
|
oral tablet,once a day for 24 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the effects on change from baseline on brain atrophy
Time Frame: pre-dose, Months 6, 12, 18, 24 and Washout
|
pre-dose, Months 6, 12, 18, 24 and Washout
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the presence of other biomarkers of neuronal degeneration
Time Frame: Day 1
|
Day 1
|
To determine the presence of other biomarkers of neuronal degeneration
Time Frame: Month 24
|
Month 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in cognitive performance
Time Frame: pre-dose, Month 6, Month 12, Month18, Month 24
|
rate of cognitive decline
|
pre-dose, Month 6, Month 12, Month18, Month 24
|
Change from baseline in global clinical status
Time Frame: pre-dose, Month 6, Month 12, Month 18, Month 24
|
pre-dose, Month 6, Month 12, Month 18, Month 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joel S Ross, MD, Memory Enhancement Center of America
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Anticipated)
March 1, 2016
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
October 31, 2012
First Submitted That Met QC Criteria
November 6, 2012
First Posted (Estimate)
November 8, 2012
Study Record Updates
Last Update Posted (Estimate)
February 10, 2015
Last Update Submitted That Met QC Criteria
February 9, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Nerve Degeneration
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Flurbiprofen
Other Study ID Numbers
- CCD-1109-PR-0072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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