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Clinical Trials
 
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New York University School of Medicine
Silberstein Institute For Aging and Dementia • Current Studies

Treatment Studies

Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease (AD) Prevention Trials in People Over 75 Years of Age

This study is examining the feasibility and accuracy of athome methods of evaluation. Participants include men and women age 75 and over, who do not have AD. Participants are randomized into one of three groups. The first group is evaluated using paper and pencil questionnaires returned by mail, plus cognitive testing over the phone with study staff. The second group is evaluated using an automated telephone method and the third group uses a special computer kiosk. Such at-home evaluations eventually may be applied to future clinical trials, making them more available and convenient for patients and caregivers. It will also be a way to reduce the cost and amount of staff time required to conduct trials, particularly large prevention studies. Participants initially receive a free brief medical and memory evaluation and then do the in-home evaluations periodically over a 4-year period. Because the study can involve the kiosk or telephone installation and initial training in the home, we are currently recruiting participants who live in the vicinity of the NYU Medical Center. For more information, please call Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.

 

New Clinical Trial of Anti-Amyloid Antibody Treatment

We will begin enrollment for a new clinical trial in late summer 2008 that involves an “immunotherapy” treatment approach. This phase III study will test the safety and effectiveness of an experimental antibody treatment that may remove or reduce beta-amyloid, which is one of the important toxic proteins that contribute to the development of Alzheimer’s disease (AD). It is hoped that this new treatment may slow the further progression of the disease. This study will enroll patients with mild-to-moderate AD who will receive either the experimental drug or placebo for up to 18 months. Study participation involves administration of study drug as an intravenous infusion, periodic visits to the study center, as well as repeated MRI scans. To receive more information about this study, please call Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.

 

New Clinical Trial of Gamma-Secretase Inhibition for Slowing Progression of
Alzheimer’s Disease (AD)

This upcoming study is expected to begin enrollment in late summer of 2008. This study will test the effectiveness of a novel compound, a gamma secretase inhibitor (Lilly LY450139) proposed to reduce the production of betaamyloid, thereby possibly slowing the rate of disease progression. Eligible participants with mild-to-moderate AD will receive either experimental drug or placebo for 23 months. All participants in the study, whether on active drug or placebo, will eventually receive the experimental drug for the latter half of the trial. For more information, please call Erica Maya or
Jessica Lerer at 212-263-5845 or 212-263-5708
.

 

New Clinical Trial of RAGE Inhibition for Slowing Progression of Alzheimer’s Disease (AD)

This study is currently enrolling. This study will test the effectiveness of a novel compound called a RAGE inhibitor (Pfizer TTP-488) which may inhibit the production of beta-amyloid, thereby possibly slowing the rate of disease progression. Eligible participants with mild-to-moderate AD will receive either experimental drug or placebo for 18 months. Visits occur approximately every three months after the first administration of the study drug. Please do not hesitate to call regarding questions of eligibility. For more information, please call Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.

 

An Interactive Museum Tour for People with Alzheimer’s Disease and their Family Members

A new study is evaluating the effectiveness of participating in a guided tour of a New York City museum specifically designed for people with Alzheimer’s disease and their family members and caregivers. It is hoped that the museum experience will improve their well-being and relationships with each other and help participants continue to partake in other activities together. If you would like to find out how to participate, please contact Olanta Barton
at 212-263-5710
or olanta.barton@med.nyu.edu.

 

New Group Interventions for People with Mild Cognitive Impairment (MCI)

This study evaluates the effects of two group interventions on the functioning of people with MCI. Adults 65 to 80 years old diagnosed with MCI will have a 50/50 chance of being assigned to either a life review group or a cognitive skills group. Both groups will meet for 90 minutes once a week for 10 weeks. It is hoped that participation will give you more effective ways to manage memory problems and provide an opportunity for social interaction with peers. This study is now in progress. If there is enough interest, future sessions will be offered. This study is a collaboration of the NYU-ADC and the NYU Rusk Institute of Rehabilitation Medicine. For more information, please contact Dr. Sharon E. McKenzie at 212-263-2078 or
Olanta Barton at 212-263-5710
.

 

EARLY AD DIAGNOSIS

Longitudinal Study of Normal Aging, Mild Cognitive Impairment (MCI) and
Alzheimer’s Disease (AD)

Participants receive a comprehensive diagnostic evaluation and are re-evaluated every year. The goal is to improve early diagnosis and better understand the clinical course and causes of age-related cognitive decline and AD. For more information, please contact Emma Shulman, CSW at 212-263-5756 or Thet Oo, M.D.
at 212-263-8088
or thet.oo@med.nyu.edu.

 

The Multicultural Program

Our Multicultural Aging and Memory Evaluation Program offers a comprehensive, multidisciplinary evaluation for elderly individuals who present with memory complaints or symptoms of dementia or Alzheimer’s disease. The mission of this program is to provide diagnostic service to the ethnic minority and underserved populations, to promote their access to early utilization of these services, and provide culturally and language-appropriate service. For more information, please contact Dorothy Patterson at 212-263-3201.

 

Positron Emission Tomography (PET) and Memory Study

This NIH-funded program uses advanced brain imaging techniques to measure the metabolic function of the brain so as to predict future cognitive impairment. This longitudinal imaging study of elderly individuals uses a new amyloid imaging scan and a proven glucose metabolism scan to better understand the differences between successful aging and the progression to memory impairment and to Alzheimer’s disease. We are developing and testing a profile of measures to identify those at increased risk for future memory impairment. Study recruitment includes individuals between 40-90 years with and without memory problems. For more information, please call Schantel Williams at 212-263-7563.

 

Cerebral Spinal Fluid (CSF) Study

This study seeks to develop a specific early Alzheimer’s disease (AD) diagnosis based on analysis of cerebrospinal fluid. This NIH supported project evaluates whether the amount and type of amyloid and tau proteins (proteins associated with AD) and isoprostanes (markers of oxidative stress) that are found in the CSF are related to memory changes and the brain shrinkage seen in MRI studies. These markers may be useful to screen early AD and to potentially follow progression and track response to treatment. Participants include normal individuals over 40 years of age, individuals with memory problems, mild cognitive impairment, and AD. For more information, please call Dr. Kenneth Rich at 212-263-7563.

 

HELPING CAREGIVERS

Support for Couples Dealing with a Recent Diagnosis of Alzheimer’s Disease (AD)

A unique free counseling study has been designed especially for people recently diagnosed with early AD and their spouses and is supported by a grant from the Alzheimer’s Association. During 6 weekly meetings with a counselor, the couple will discuss problems resulting from the illness and workable responses to them. Couples will be encouraged to share thoughts and feelings, and find ways to help and support each other. For more information, please call Cynthia Epstein, ACSW at 212-263-1056 or Ursula Auclair, LCSW at 212-263-2245.

 

Counseling and Support for People Caring for a Parent with Alzheimer’s Disease (AD)

The purpose of this NIH-funded study is to determine the effectiveness of a comprehensive counseling and support intervention for people who care for parents with AD. Participants will be randomly assigned to one of two interventions. All participants have access to resource information and support from experts as needed. Those in the enhanced group will meet with a counselor individually and with other family members. Based on an earlier research program, we expect that all participants will experience significant benefits to their well-being, including reduced stress and depression and postponed nursing home placement of their parents. If you are the ‘primary’ caregiver of the person with a diagnosis of dementia (i.e., the first person called if the patient is in need of help) and a daughter, son, daughter-in-law, or son-inlaw of the person with AD and would like more information, please contact Olanta Barton at 212-263-5710 or olanta.barton@med.nyu.edu.

 

For Caregivers of Parents in the Middle Stage of Alzheimer’s Disease (AD)

This study is investigating an education and support intervention designed to reduce the stress, anxiety, and depression frequently experienced by people whose parents are in the moderate stage of AD. Everyone who enrolls receives self-teaching materials especially written for this project and the opportunity to consult a counselor for resource information as needed. Half the participants, chosen at random, will also receive 2 workshops and an individual counseling session. For more information, please contact Olanta Barton at 212-263-5710 or olanta.barton@med.nyu.edu.

 

Memantine (Namenda™) and Individualized Alzheimer’s Care

Are you caring for someone who is in the middle or late stage of Alzheimer’s? Would you like to see them function and feel better? Would you like to solve the empty day syndrome? The goal of this study is to determine the added value of an individualized patient management program in AD patients receiving Memantine. Subjects with moderate-to-severe AD are eligible. All patients receive Memantine and follow-up evaluations at no charge. In addition, patients are randomly assigned to one of two groups. One group receives compensation and the other receives an individualized program consisting of caregiver training and support as well as home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation. The study duration is one year. For more information, please contact Dr. Sunnie Kenowsky at 212-263-7164
or sunnie.kenowsky@med.nyu.edu.

 

OTHER PROGRAMS

Brain Donation Program

The NYU ADRC team is very grateful to donors and their families for participation in our Brain Donation Program. Brain autopsy provides a definitive diagnosis for families while contributing to important research on the causes and treatment of brain aging and Alzheimer’s disease. Volunteers with and without memory impairment are eligible for participation in this program. For more information, please call 212-263-5108.

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