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The Predictor’s Study; A Longitudinal Study of Dementia

Principle Investigators
Yaakov Stern, PhD., Columbia University
Jason Brandt, PhD., Johns Hopkins University School of Medicine
Deborah Blacker, MD., ScD, Massachusetts General Hospital

Agency of Study
Columbia Presbyterian Hospital; New York, NY
Johns Hopkins University School of Medicine; Baltimore, MD
Massachusetts General Hospital; Boston, MA

Purpose of Study
The purpose of this study is to learn more about memory disorders associated with aging. We will gather detailed information about the symptoms of people with Dementia with Lewy Bodies (DLB) in order to better predict the progression of this illness. These prediction models will provide caregivers and physicians with valuable information that will help in better managing memory disorders associated with aging such as DLB.

Characteristics/Requirements for Recruiting Participants
We are currently focusing our efforts on recruiting participants who have a diagnosis of Dementia with Lewy Bodies and who have someone willing to serve as an informant. Informants must be capable of providing detailed information about the participant’s cognitive, functional and emotional status. Informants should have regular contact with the participant; however, it is not necessary for the informant to be a relative, or to see the patient on a daily basis. Participants are excluded from the study if they have a history of stroke, schizophrenia prior to onset of intellectual decline, a history of alcohol abuse or dependency, or a diagnosis of Parkinson’s disease or parkinsonism one year prior to the onset of intellectual decline or memory loss.

Procedures Involved, Including Length of Study
The study involves a one hour evaluation every six months. During this evaluation, the participant will be given a brief paper-and-pencil test of memory and thinking and a short interview regarding his or her daily activities and ability to communicate. In addition, the informant will be interviewed regarding the participant’s day-to-day functioning, hobbies, interest, mood, and behavior. In the event that the participant has trouble making a decision about continuing study involvement, the informant can serve as a surrogate to help the participant with this decision. This study is designed to follow people for as long as possible to create a complete picture of the full course of DLB. Therefore, participants are asked to come in every 6 months for as long as they wish to continue participation in the study.

In addition, we ask the participant for permission to obtain a blood sample. This sample helps to provide invaluable information about how variations in chromosomes influence the course of DLB and other age associated memory problems. The blood will be processed with a code number and all information will remain confidential. The blood draw is an optional part of the study and is not necessary for study participation.

Potential Risks to Participants
The study involves minimal risk to participants. The patient may experience slight pain due to the blood test; there will likely be pain on insertion of the needle into the vein, and there might be slight bruising at the location of the blood draw. Additionally, the patient may experience some frustration or mild anxiety during the paper-and-pencil tests.

Human Subjects Review Approval
Approved by the New York State Psychiatric Institute- Columbia University Department of Psychiatry Institutional Review Board from January 27, 2007 to January 26, 2008.

Contact Person & Method for Volunteering to Participate

Please call the following study coordinators if you or someone you know may be interested in the Predictor’s Study:

Columbia University: Oksana Tatarina: (212) 305-1987 or Nick Adams: (212) 342-0522
Johns Hopkins School of Medicine: Jaclyn Samek or Eleanor Neijstrom: (410) 955-1647
Harvard Medical School:  Sheela Chandrashekar: 617-726-5571