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Completed

NCT Number: NCT01745198

Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Alzheimer's Disease Alzheimer's Disease Related Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Depression Homocysteinemia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

    Change in MPI over time will be calculated using multiple retrospective time points.

Secondary outcomes

  1. Change in rate of cognitive decline as measured by the MCI Screen

    Time frame: Baseline to end of study (estimated average of 48 months)

    Change in MCI Screen over time will be calculated using multiple retrospective time points.

  2. 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)

    Change in CERAD drawings over time will be evaluated using multiple retrospective time points

  3. Change in rate of cognitive decline as measured by Trails A & B

    Time frame: 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

  4. Rate of atrophy of hippocampal volume

    Time frame: Baseline to end of study (estimated average of 48 months)

    Decrease in hippocampal volume over time will be assessed using volumetric MRI

  5. Rate of atrophy in cortical volume

    Time frame: Baseline to end of study (estimated average of 48 months)

    Decrease in cortical volume over time will be assessed using volumetric MRI

  6. Rate of atrophy in ventricular volume

    Time frame: Baseline to end of study (estimated average of 48 months)

    Decrease in ventricular volume over time will be assessed using volumetric MRI

  7. 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)

    Change in FAST over time will be calculated using multiple retrospective time points.

Sponsors and collaborators

Lead sponsor

Pamlab, Inc.

Industry

Collaborators

  • Hoag Memorial Hospital Presbyterian
  • The Shankle Clinic

Registry information

Official study title

Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Related Disorders

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2012
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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