Subjective Memory Loss in Older Persons Clinical Trial
Official title:
A Six-month, Double-blind, Placebo-controlled, Single Site Study of Cerefolin NAC on Blood Homocysteine, Oxidative Stress, and Beta-amyloid Biomarkers That May Potentiate Inflammation and Neuronal Damage in Older Individuals With Memory Complaints Who Have Not Been Clinically Diagnosed With Mild Cognitive Impairment, Vascular Dementia, or Alzheimer's Disease
| Verified date | May 2013 |
| Source | Rush University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this six-month research study is to determine if Cerefolin NAC reduces levels of substances in the blood that may be associated with thinking ability and the health of brain cells in subjects with memory concerns when compared to a standard multivitamin. Cerefolin NAC is available as a dietary supplement via a prescription from a physician. The multivitamin used in the study contains the Recommended Daily Intake recommended for older persons.
| Status | Completed |
| Enrollment | 104 |
| Est. completion date | May 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - Age greater than 60; - Memory complaints as defined by two questions: 1. "Do The subject think your have memory problems?"; and, 2. "Has there been a decline in your memory over the last 10 years?" - Fluency in English; - Ability to ingest oral medications; and, - Willing to replace current vitamin intake with a standardized multivitamin provided for the study. Exclusion Criteria: - Clinical stroke or Parkinson's disease; - Taking FDA approved drug for symptomatic treatment of Alzheimer's disease (Aricept, Razadyne, Exelon, and/or Namenda); - History of significant renal insufficiency (creatinine =1.5); - History of renal stones or peptic ulcer disease; - Use of vitamin supplements containing more than 400mcg of folic acid per day within 2 months of Screen Visit; - As determined by the study physician, clinically significant serum folate and vitamin B12 deficiency on screening blood tests that would require further clinical evaluation and treatment - As determined by the study physician, clinically significant medical conditions, physical exam findings or abnormal blood tests at screening that would require further clinical evaluation and treatment - B12 injections 6 months prior to the Screen Visit; - Confirmed clinical diagnosis of Mild Cognitive Impairment (MCI), vascular dementia or Alzheimer's Disease (AD); and, - Known hypersensitivity to L-methylfolate, methyl-cobalamin or N-acetylcysteine. - Use of any other investigational agent used during the 30 days prior to Screening. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Rush Alzheimer's Disease Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Rush University Medical Center | Pamlab, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aß42 to Aß40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only | Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aß42 and Aß40. Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method. Enzyme-linked immunosorbent assays (ELISA) were used for Aß42 (Wako Chemicals USA, Inc., Richmond, VA) and Aß40 (Invitrogen Corporation, Canarillo, CA) detection. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline. Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs). A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aß42 to Aß40 ratio) to declare the study positive. | 6 months | No |
| Secondary | Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only | Mean study product compliance was measured as the actual number of study product tablets taken as a percent of the maximum study product tablets that could have been taken during the intervention period. | 6 months | No |
| Secondary | Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only | Outcome measures were 6-month levels of highly sensitive c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), malondialdehyde, and potential anti-oxidant (PAO)in blood samples as a percent of baseline value. | 6 months | No |