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Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
The Shankle Clinic
Hoag Memorial Hospital Presbyterian
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT01745198
First received: December 3, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition
Mild Cognitive Impairment
Alzheimer's Disease
Alzheimer's Disease Related Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Related Disorders

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Change in MPI over time will be calculated using multiple retrospective time points.


Secondary Outcome Measures:
  • Change in rate of cognitive decline as measured by the MCI Screen [ Time Frame: Baseline to end of study (estimated average of 48 months) ] [ Designated as safety issue: No ]
    Change in MCI Screen over time will be calculated using multiple retrospective time points.

  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to end of study (estimated average of 48 months) ] [ Designated as safety issue: No ]
    Change in Trails A & B over time will be assessed using multiple retrospective time points

  • Rate of atrophy of hippocampal volume [ Time Frame: Baseline to end of study (estimated average of 48 months) ] [ Designated as safety issue: No ]
    Decrease in hippocampal volume over time will be assessed using volumetric MRI

  • Rate of atrophy in cortical volume [ Time Frame: Baseline to end of study (estimated average of 48 months) ] [ Designated as safety issue: No ]
    Decrease in cortical volume over time will be assessed using volumetric MRI

  • Rate of atrophy in ventricular volume [ Time Frame: Baseline to end of study (estimated average of 48 months) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to end of study (estimated average of 48 months) ] [ Designated as safety issue: No ]
    Change in FAST over time will be calculated using multiple retrospective time points.


Biospecimen Retention:   Samples With DNA

A single blood draw for approximately 6-10 mL of blood will be performed for the total plasma homocysteine measurement and genetic studies.


Estimated Enrollment: 119
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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®.
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®.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745198

Locations
United States, California
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Sponsors and Collaborators
Pamlab, Inc.
The Shankle Clinic
Hoag Memorial Hospital Presbyterian
Investigators
Principal Investigator: William R Shankle, MS, MD, FACP Shankle Clinic
  More Information

No publications provided

Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01745198     History of Changes
Other Study ID Numbers: NAC-002c
Study First Received: December 3, 2012
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pamlab, Inc.:
homocysteinemia
dementia
depression
vitamin B12
folate
mild cognitive impairment
alzheimer's
homocysteine

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Disease
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014