Alzheimer's Disease, Alzheimer's Disease Related Disorders, Mild Cognitive Impairment
Conditions
Keywords
homocysteinemia, dementia, depression, vitamin B12, folate, mild cognitive impairment, alzheimer's, homocysteine
Brief summary
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.
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.
Interventions
None listed
Sponsors
The Shankle Clinic
Hoag Memorial Hospital Presbyterian
Pamlab, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in rate of cognitive decline as measured by the Memory Performance Index (MPI) | Baseline to end of study (estimated average of 48 months) | Change in MPI over time will be calculated using multiple retrospective time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings | Baseline to end of study (estimated average of 48 months) | Change in CERAD drawings over time will be evaluated using multiple retrospective time points |
| Change in rate of cognitive decline as measured by Trails A & B | Baseline to end of study (estimated average of 48 months) | Change in Trails A & B over time will be assessed using multiple retrospective time points |
| Rate of atrophy of hippocampal volume | Baseline to end of study (estimated average of 48 months) | Decrease in hippocampal volume over time will be assessed using volumetric MRI |
| Change in rate of cognitive decline as measured by the MCI Screen | Baseline to end of study (estimated average of 48 months) | Change in MCI Screen over time will be calculated using multiple retrospective time points. |
| Rate of atrophy in ventricular volume | Baseline to end of study (estimated average of 48 months) | Decrease in ventricular volume over time will be assessed using volumetric MRI |
| Change in rate of cognitive decline as measured by Functional Assessment Staging Test (FAST) | Baseline to end of study (estimated average of 48 months) | Change in FAST over time will be calculated using multiple retrospective time points. |
| Rate of atrophy in cortical volume | Baseline to end of study (estimated average of 48 months) | Decrease in cortical volume over time will be assessed using volumetric MRI |
Countries
United States
Outcome results
None listed