An observational study in Mild Cognitive Impairment, Alzheimer's Disease and Alzheimer's Disease Related Disorders, sponsored by Pamlab, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-28.
Sponsored by Pamlab, Inc. (part of Alfasigma S.p.A.) · Observational
In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data.
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.
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's enrollment of 121 is below the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Pamlab, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) will be matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group).
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Exclusion Criteria:
Subjects who do not meet the inclusion criteria will be excluded from the study.
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®.
This group consists of patients not diagnosed with homocysteinemia who have no past or current treatment with Vitamin B12, Folate or Cerefolin®/CerefolinNAC®.
Change in rate of cognitive decline as measured by the Memory Performance Index (MPI)
Change in MPI over time will be calculated using multiple retrospective time points.
Time frame: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by the MCI Screen
Change in MCI Screen over time will be calculated using multiple retrospective time points.
Time frame: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings
Change in CERAD drawings over time will be evaluated using multiple retrospective time points
Time frame: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by Trails A & B
Change in Trails A \& B over time will be assessed using multiple retrospective time points
Time frame: Baseline to end of study (estimated average of 48 months)
Rate of atrophy of hippocampal volume
Decrease in hippocampal volume over time will be assessed using volumetric MRI
Time frame: Baseline to end of study (estimated average of 48 months)
Rate of atrophy in cortical volume
Decrease in cortical volume over time will be assessed using volumetric MRI
Time frame: Baseline to end of study (estimated average of 48 months)
Rate of atrophy in ventricular volume
Decrease in ventricular volume over time will be assessed using volumetric MRI
Time frame: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by Functional Assessment Staging Test (FAST)
Change in FAST over time will be calculated using multiple retrospective time points.
Time frame: Baseline to end of study (estimated average of 48 months)
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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