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Memory Disorders Program

georgetown university, washington dc

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Treatment Trials:

 

 

 

 

Treatment Trials:

DHA Closed for Enrollment

DHA (Docosahexaenoic Acid) is the main omega-3 fatty acid in our brain and eyes. It is a nutrient found in fish and algae and previous studies suggest that it is the key part of fish oil that protects the brain. This study will determine whether chronic DHA supplementation slows the progression of cognitive and functional decline in mild to moderate Alzheimer’s disease. Participants receive oral medication in the form of soft gel tablets that they are instructed to take every day for 18 months.

Enrollment Criteria - Individuals who are 50 years of age or older with a diagnosis of mild to moderate Alzheimer’s disease. The participants have a minimal amount of fish intake in their normal diets.

Scheduling requirements - This study involves eight visits over the course of 18 months.

For more information about the study, please contact Farida Sita at (202) 687-8800 or via email: fs223@georgetown.edu.

 

Elan Antibody Study Closed for Enrollment

This study will assess whether AAB-001, an investigational medication not yet approved for use, is safe, well tolerated and effective for use in persons with mild to moderate Alzheimer's disease.  AAB-001 is an antibody that it is hoped will attach to amyloid protein in the brain (thought to cause symptoms like memory loss and confusion) and help in its removal from the body. Participants receive medication through an intravenous infusion on six occasions and will also undergo a battery of memory tests and multiple MRI (magnetic resonance imaging) scans.

Enrollment Criteria - Participants must be between the ages of 50 and 85 and have a diagnosis of mild to moderate probable Alzheimer's disease.

Scheduling Requirement - This study requires at least 25 visits over the course of the study (approximately 27 months). Length of study visits varies.

For more information about the study, please contact Kelly Behan at (202) 687-0413 or via email: keb53@georgetown.edu.

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Flurizan Closed for Enrollment

Certain drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs, have been shown to reduce levels of beta-amyloid, a protein fragment considered a prime suspect behind the cognitive decline in Alzhiemer's disease. Flurizan, a drug chemically related to NSAIDs, seems to have a strong impact on beta-amyloid, but with few to none of the side effects normally associated with anti-inflammatory drugs. The purpose of this study is to determine the possible benefits of Flurizan on the cognition and daily functioning of Alzheimer's patients.

Enrollment Criteria - Adults over the age of 55 experiencing the cognitive impairment of probable mild Alzheimer's disease.

Scheduling Requirements - There are 10 study visits, approximately 3 months apart after the initial screening visit, over the course of 18 months.

For more information about the study, please contact Farida Sita at (202) 687-8800 or via email: fs223@georgetown.edu.

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Huperzine A Closed for Enrollment

Huperzine A is a natural product extracted from a Chinese herb. There is growing evidence that huperzine A not only compares favorably in symptomatic efficacy to cholinesterase inhibitors in current use, but additionally has both antioxidant and neuroprotective properties, effects which may be relevant in the treatment of Alzheimer's Disease. Studies to date suggest that huperzine A is well tolerated. This study examines the effects of huperzine A on the rate of cognitive decline in individuals with Alzheimer's disease.

Enrollment Criteria - Participants must be at least 55 years of age with mild to moderate Alzheimer's disease. Subjects may not be taking Aricept, Reminyl, Exelon or Cognex within the last three months.

Scheduling Requirements - This study involves nine clinic visits over a six month period.

To view a printable brochure that describes the study click here, or go to http://adcs.ucsd.edu/Huperzine_protocol.htm.  For more information about participating in this study, please contact Kelly Behan at (202) 687-0413 or via email: keb53@georgetown.edu.

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Lilly Antibody Study Closed for Enrollment

This study involves use of an investigational drug called LY20630, which
has not been approved by the U.S. Food and Drug Administration (FDA).  This drug is an experimental antibody under development for the treatment of Alzheimer’s disease. Eli Lilly and Company, Inc. sponsors this study. Its purpose is to look at the safety and tolerability of this medication in two subject groups:  individuals with mild-to-moderate Alzheimer’s disease and healthy volunteers. Participants will also complete a series of memory tests, physical exams, and lumbar punctures (spinal tap).  Subjects will also have the option of participating in an imaging protocol.

Enrollment Criteria - Both health volunteers and patients must be at least 50 years of age. Patients must have a diagnosis of mild to moderate probable Alzheimer's disease.

Scheduling Requirement -  Individuals with Alzheimer’s disease will receive 12 weekly intravenous infusions of either LY1062430 or placebo.  Health volunteers will receive a single infusion of LY1062430 or placebo.  Subjects will be followed for an additional 9 months after ending study medication.

For more information about the study, please contact Farida Sita (202) 687-8800 or via email: fs223@georgetown.edu.

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MEM 1003 Closed for Enrollment

MEM 1003, is an investigational medication not yet approved for use, that is being tested for safety, tolerance and effectiveness in persons with mild to moderate Alzheimer's disease. There is growing support for the view that alterations in intraneuronal calcium homeostasis play a significant role in the initial pathophysiology and progressive decline of cognitive processes in Alzheimer’s disease. Attempts to address this dysregulation by compounds such as MEM 1003 (a calcium channel blocker) may have the potential for decreasing cell toxicity and neuronal protection.

Enrollment Criteria - Individuals who are between 50 and 90 years of age (inclusive) who have a diagnosis of mild to moderate Alzheimer's disease. Participants may NOT currently be taking Namenda (memantine).

Scheduling Requirements - This study involves 8 clinic visits over 16 weeks.
For more information about the study, please contact Kelly Behan at (202) 687-0413 or via email: keb53@georgetown.edu.

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Merck Vaccine

This study is a Phase I (first in humans) active immunotherapy trial sponsored by Merck Pharmaceuticals. The vaccine aims to activate the immune system to eliminate the amyloid molecule that is believed to cause Alzheimer's disease. Participants must complete multiple brain scans and lumbar puncture procedures along with routine study visits.

Enrollment Criteria - Individuals over the age of 50 who have a diagnosis of mild to moderate Alzheimer's disease and who are otherwise in general good health.

Scheduling Requirements - This study involves 17 visits over the course of 3 years.

For more information about this study please contact Brigid Reynolds, N.P. at (202) 687-3350 or vial email: bar23@georgetown.edu.

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Nicotine Closed for Enrollment

Nicotine plays an important role in the functional impairment of Alzheimer's disease and previous studies have shown that the loss of nicotinic receptors in the brain may be related to cognitive disturbances in Alzheimer's disease. This study investigates whether transdermal nicotine improves attention, learning and memory in subjects with mild cognitive impairment.

Enrollment Criteria - Individuals who are 55 years of age and older who meet specific criteria for Mild Cognitive Impairment.

Scheduling Requirements - This study involves eight clinic visits over 12 months.

For more information about the study, please contact Kelly Behan at (202) 687-0413 or via email: keb53@georgetown.edu.

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Valproate Closed for Enrollment

Valproate is a medication with both anti-seizure and mood stabilizing properties. This study investigates whether valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer's disease who have never experienced these symptoms throughout their course of illness. It also investigates the hypothesis that Valproate slows disease progression in Alzheimer's disease.

Enrollment Criteria - Participants must be at least 55 years of age with mild to moderate cognitive impairment of probable Alzheimer's disease. There must be no history of present/previous agitation or psychosis requiring psychotropic medication since the illness began.

Scheduling Requirements - Study visits occur at approximately three monthly intervals over 26 months.

Additional information on this study is available at http://adcs.ucsd.edu/Valproate_protocol.htm. For information about participation in this study  please contact Kelly Behan at (202) 687-0413 or via email: keb53@georgetown.edu.

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Vitamin E/Down Syndrome Closed for Enrollment

The goal of this study is to determine whether vitamin E, which has been shown to delay the progression of Alzheimer's disease, will slow the rate of cognitive/functional decline in older individuals with Down syndrome. It is well known that individuals with Down syndrome are uniquely vulnerable to Alzheimer's disease with many having symptoms of dementia by the age of 50. Vitamin E is an anti-oxidant with properties that may prove beneficial in delaying the onset and progression of Alzheimer's disease in individuals with Down syndrome.

Enrollment Criteria - Individuals age 50 or over with Down syndrome.

Scheduling Requirements - Study visits occur at six-month intervals over a three-year period.

For more information about the study, please contact Kelly Behan at (202) 687-0413 or via email: keb53@georgetown.edu.

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