A Phase 1 interventional study of Etanercept and Curcum.Luteol.Theaflav.Lip.Acid,FishOil,Quercet.,Resveratr. in Alzheimer's Disease, sponsored by Life Extension Foundation Inc.. Completed at 2 sites in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Life Extension Foundation Inc. · Phase 1, Interventional, and Health services research
While the cause of AD is still unknown, evidence suggests it develops because of a complex series of events in the brain that occur over time. Two pathways possibly involved in development of AD are inflammation and oxidative stress. Scientists have linked chronic inflammatory events in the brain with the onset and progression of Alzheimer's Disease. Oxidative stress has also been implicated in the pathogenesis of a number of neurological disorders including Alzheimer's Disease.
Etanercept (Enbrel®) is an approved drug for the treatment of several forms of arthritis when administered by injection. Some research suggests that etanercept, when administered by injection into the tissues close to the spinal column (perispinally), may modulate certain aspects of the immune system and provide some beneficial effect for people with Alzheimer's disease. Studies suggest that supplementation with specific nutrients may also have a positive effect in support of cognitive function.
This study will be conducted at one research office with volunteers who have been diagnosed with mild to moderate Alzheimer's disease. Each qualifying participant will be randomly assigned to receive an etanercept injection plus nutritional supplements for 6 weeks followed by a crossover and a washout period of 4 weeks to then receiving nutritional supplements alone or vice versa for another 6 weeks.
Participants will undergo blood and urine safety assessments at the beginning and end of each 6 week treatment period. During 4 of the 6 weekly visits in the treatment period with the injections, you will complete the cognitive tests twice; once before and once 2 hours after the injection. During 4 of the 6 weekly visits in the treatment period without the injections, you will also complete the cognitive tests twice; once before and once 2 hours after being asked to lie down onto a table for 5 minutes. You will be allowed to continue your standard of care for Alzheimer's disease throughout your participation in the study.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 12 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Life Extension Foundation Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25 mg administered weekly for 6 weeks
Biological: Etanercept · Dietary Supplement: Curcum.Luteol.Theaflav.Lip.Acid,FishOil,Quercet.,Resveratr.
Nutritional supplements administered daily for 6 weeks in each period as well as an additional 12 weeks following visit 15.
Dietary Supplement: Curcum.Luteol.Theaflav.Lip.Acid,FishOil,Quercet.,Resveratr.
Also known as: Enbrel®
Also known as: Super Bio-Curcumin, Super Omega-3, Optimized Quercetin, Optimized Resveratrol
Difference in effects of treatment for 6 weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Mini-Mental Status Examination (MMSE) score.
Time frame: 16 weeks
Difference in the effects of treatment for 6 weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) score.
Time frame: 16 weeks
Difference in the effects of treatment for 6 weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Montreal Cognitive Assessment (MoCA) score.
Time frame: 16 weeks
Difference in the effects of treatment for 6 weeks as well as an additional 12 weeks following visit 15 with nutritional supplementation alone on the MMSE score.
Time frame: 28 weeks
Difference in short term effects of etanercept on the MMSE score before and two hours after perispinal administration of etanercept.
Time frame: 16 weeks
To determine the safety and tolerability of nutritional supplements with perispinal adminstration of etanercept, as measured by various laboratory markers, vital signs (blood pressure and heart rate), and adverse events.
Time frame: 16 weeks
Difference in the effects of treatment for 6 weeks as well as an additional 12 weeks following visit 15 with nutritional supplementation alone on the ADAS-cog score.
Time frame: 28 weeks
Difference in the effects of treatment for 6 weeks as well as an additional 12 weeks following visit 15 with nutritional supplementation alone on the MoCA score.
Time frame: 28 weeks
Difference in short term effects of etanercept on the ADAS-cog score before and two hours after perispinal administration of etanercept.
Time frame: 16 weeks
Difference in short term effects of etanercept on the MoCA score before and two hours after perispinal administration of etanercept.
Time frame: 16 weeks
To determine the safety and tolerability of nutritional supplements without perispinal adminstration of etanercept, as measured by various laboratory markers, vital signs (blood pressure and heart rate), and adverse events.
Time frame: 16 weeks
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Life Extension Foundation Inc.