- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745198
Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements
Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Related Disorders
Study Overview
Status
Detailed Description
CerefolinNAC® is an orally administered prescription medical food, and is formulated as a combination of L-methylfolate calcium (as Metafolin®), methylcobalamin, and N-acetylcysteine. In a retrospective analysis, disease-delaying effects of Cerefolin®/CerefolinNAC® (CFLN) are examined in terms of cognition (measured by MCI Screen (MCIS)), and functional capacity (measured by Functional Assessment Staging Test (FAST)). - the treatment effect of CFLN on cognitive and functional measures, and on biomarker measures in patients with Alzheimer's disease and related disorders (ADRD).
The current study will expand the NAC-002b study dataset by prospectively collecting additional biomarker and imaging data in a more comprehensively assessed, matched sample of patients. This will allow more precise evaluation of cognitive and functional outcome measures, and biomarker measures will be assessed in an attempt to identify specific populations or conditions in which CFLN is most effective.
The sample will consist of patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group). Also 65 additional subjects will be recruited for the non-Treatment group, which will be used to improve the rate of decline estimates for the cognitive and functional outcome measures.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Newport Beach, California, United States, 92663
- Hoag Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- With a diagnosis of normal aging (NL), cognitive impairment or dementia not otherwise specified (CI/D), or ADRD
- With at least one previous quantitative MRI (qMRI)
- With at least one previous homocysteine level
- Without homocysteinemia plus no past or current B12, folate or Cerefolin® treatment, OR with homocysteinemia plus past or current Cerefolin® treatment
Exclusion Criteria:
Subjects who do not meet the inclusion criteria will be excluded from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Treatment Group
This group consists of patients diagnosed with homocysteinemia who have been treated with Cerefolin®/CerefolinNAC® in the past or are currently being treated with Cerefolin®/CerefolinNAC®.
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Non-Treatment Group
This group consists of patients not diagnosed with homocysteinemia who have no past or current treatment with Vitamin B12, Folate or Cerefolin®/CerefolinNAC®.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in rate of cognitive decline as measured by the Memory Performance Index (MPI)
Time Frame: Baseline to end of study (estimated average of 48 months)
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Change in MPI over time will be calculated using multiple retrospective time points.
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Baseline to end of study (estimated average of 48 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in rate of cognitive decline as measured by the MCI Screen
Time Frame: Baseline to end of study (estimated average of 48 months)
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Change in MCI Screen over time will be calculated using multiple retrospective time points.
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Baseline to end of study (estimated average of 48 months)
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Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings
Time Frame: Baseline to end of study (estimated average of 48 months)
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Change in CERAD drawings over time will be evaluated using multiple retrospective time points
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Baseline to end of study (estimated average of 48 months)
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Change in rate of cognitive decline as measured by Trails A & B
Time Frame: Baseline to end of study (estimated average of 48 months)
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Change in Trails A & B over time will be assessed using multiple retrospective time points
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Baseline to end of study (estimated average of 48 months)
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Rate of atrophy of hippocampal volume
Time Frame: Baseline to end of study (estimated average of 48 months)
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Decrease in hippocampal volume over time will be assessed using volumetric MRI
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Baseline to end of study (estimated average of 48 months)
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Rate of atrophy in cortical volume
Time Frame: Baseline to end of study (estimated average of 48 months)
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Decrease in cortical volume over time will be assessed using volumetric MRI
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Baseline to end of study (estimated average of 48 months)
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Rate of atrophy in ventricular volume
Time Frame: Baseline to end of study (estimated average of 48 months)
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Decrease in ventricular volume over time will be assessed using volumetric MRI
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Baseline to end of study (estimated average of 48 months)
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Change in rate of cognitive decline as measured by Functional Assessment Staging Test (FAST)
Time Frame: Baseline to end of study (estimated average of 48 months)
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Change in FAST over time will be calculated using multiple retrospective time points.
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Baseline to end of study (estimated average of 48 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William R Shankle, MS, MD, FACP, Shankle Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAC-002c
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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