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| Clinical Trials - Mount Sinai School of Medicine |
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CONCERT: A Phase 3 Study Evaluating Dimebon in
Alzheimer’s Patients on Donepezil
Mount Sinai researchers will be participating in a phase
3 study being conducted nationwide to evaluate how
well and how safe a study medication, Dimebon, is in
combination with donepezil (Aricept®) in patients
diagnosed with mild-to-moderate Alzheimer’s disease
(AD). Study participants will receive active study drug or
placebo (inactive pill) for 12 months, the duration of the
study, while continuing to take the prescribed donepezil.
For more information, please contact Andrew Vigario at 212-241-5692
or andrew.vigario@mssm.edu. MSSM #09-0279; MSSM approved
through 3/23/10.
Investigational Clinical Amyloid Research in
Alzheimer’s
Volunteers are being sought to participate in a clinical
study to evaluate the safety and effectiveness of an
investigational drug to help control the progression
of Alzheimer’s disease. Study participants will be
randomized to investigational product or placebo. For
more information, please contact George Marzloff at 212-241-1514
or george.marzloff@mssm.edu. GCO #08-0241, 08-0242; MSSM
approved through 2/6/10.
EPIX PRX-03140 202 Combination
There is a new phase 2 study to evaluate the efficacy
and safety of an experimental drug, PRX-03140, in
combination with donepezil-treated patients with
Alzheimer’s disease. Volunteers will receive either active
study drug or placebo for approximately 6 months,
the duration of the study, while continuing to take the
prescribed donepezil. For more information, please contact
Danielle Charney at 212-659-8883 or danielle.charney@mssm.edu.
GCO #08-0962; MSSM approved through 10/6/09.
EPIX PRX-03140 203 Monotherapy
There is a new phase 2 study to evaluate the efficacy
and safety of an experimental drug, PRX-03140, for the
potential treatment of Alzheimer’s disease. Volunteers
will receive active study medication, donepezil, or
placebo for approximately 4 or 7 months, the duration
of the study. For more information, please contact Danielle
Charney at 212- 659-8883 or danielle.charney@mssm.edu. GCO
#08-0961; MSSM approved through 10/6/09.
The Home-Based Assessment Study
Participants are randomly assigned to one of three inhome assessment methods – a telephone, electronic kiosk,
or mail-in forms — and their memory and thinking skills
will be assessed using their particular method monthly,
quarterly, or annually for a 4-year period. For more
information, please contact Jessica Egan at 718-584-9000 ext 1704.
GCO #91-208(13); MSSM approved through 8/31/09.
Trial of a Nutritional Supplement in Alzheimer’s
Disease
A study investigating whether an antioxidant formula
containing resveratrol can help memory and thinking
of Alzheimer’s disease patients. Some study participants
will receive the formula (8 oz. of grape juice twice a day
with medication in it) and some will receive a placebo
(sugar pill). For more information, please contact Danielle Charney
at 212-659-8883 or danielle.charney@mssm.edu. GCO #05-1394;
MSSM approved through 4/30/10.
Antipsychotic Discontinuation in Alzheimer’s Disease
This study examines the treatment of participants’
behavioral and psychiatric symptoms (e.g., agitation,
aggression, pacing, paranoia, hallucinations) with
risperidone, a medication known to improve these
symptoms. For more information, please contact Andrew Vigario
at 212-241-5692 or andrew.vigario@mssm.edu. GCO #06-0930;
MSSM approved through 8/31/09.
Brain Tissue Donation Program
The goal of this program is to improve existing treatments
and to develop new treatments for AD, which is not possible
without the generosity and altruism of individuals who
partner with Mount Sinai by participating in our brain
donation program. Therefore, men and women, with and
without memory impairment are eligible to provide their
“intent” to consent for this program. For more information,
please contact Karen Dahlman, Ph.D. at 212-241-1844. GCO #84-119
and #79-141, MSSM IRB approved through 3/31/10.
Note: Spanish-speaking participants are welcome in all studies. All
study participants receive reimbursement for any related expenses.
Participants without AD receive monetary compensation for their time.
If you are interested in any of the above research studies, please
contact the Alzheimer’s Disease Research Center at 212-241-8329.
Mount Sinai also has Satellite clinics specializing in AD and other
Memory Disorders located at:
Elmhurst Hospital in Queens: 718-334-3983
Bronx VA Medical Center: 718-584-9000 ext. 5199
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