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Search / Trial NCT01745198

Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements

Launched by PAMLAB, INC. · Dec 6, 2012

Trial Information

Current as of June 28, 2025

Completed

Keywords

Homocysteinemia Dementia Depression Vitamin B12 Folate Mild Cognitive Impairment Alzheimer's Homocysteine

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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.

About Pamlab, Inc.

Pamlab, Inc. is a leading clinical trial sponsor dedicated to advancing innovative therapeutic solutions for patients with complex health conditions. With a strong focus on precision medicine, the company specializes in the development of nutraceuticals and pharmaceuticals aimed at improving patient outcomes in areas such as metabolic health and neurological disorders. Pamlab, Inc. leverages its expertise in research and development, along with strategic collaborations, to conduct rigorous clinical trials that adhere to the highest regulatory standards. Committed to scientific integrity and patient safety, Pamlab, Inc. strives to deliver meaningful advancements in healthcare through its robust pipeline of evidence-based products.

Locations

Newport Beach, California, United States

Patients applied

0 patients applied

Trial Officials

William R Shankle, MS, MD, FACP

Principal Investigator

Shankle Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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