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Memory Disorders Registry

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ClinicalTrials.gov Identifier: NCT00654563
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : March 27, 2012
Sponsor:
Information provided by:
Cedars-Sinai Medical Center

Tracking Information
First Submitted Date April 3, 2008
First Posted Date April 8, 2008
Last Update Posted Date March 27, 2012
Study Start Date August 2007
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Memory Disorders Registry
Official Title Memory Disorders Registry
Brief Summary The study is designed to collect data regarding the clinical course and outcome of patients suffering from memory disorders. Visits are charged to the individual's insurance inclusive of Medicare. Patients benefit from expert evaluation and treatment recommendations. Participants may be eligible for participation in experimental treatments in the future.
Detailed Description

The purpose of this long-term, observational patient outcome registry at Cedars-Sinai Medical Center is to collect information about subjects with memory disorders from their clinical care and treatment outcome(s). It plans to examine predictors of treatment outcomes among those individuals who enroll.

Currently, there are no curative treatments for memory disorders, and this study hopes to collect information on the disorders. Over the next 6 years, this registry expects to recruit 600 adults over the age of 18 who are concerned that they may have a memory problem, or who have been diagnosed with a memory problem such as occurs in Age Associated Memory Impairment, Alzheimer's disease, Vascular Dementia, Mixed Dementia, Dementia with Lewy Bodies, Frontotemporal Dementia, Parkinson's disease, or Huntington's disease.

The Memory Disorders Program owes its existence to patients agreeing to have their clinical information kept in a database for quality control and research purposes. This data will include physical and cognitive exams, laboratory tests and scans as well as information about their medications. Many potential subjects will call in with interest in our Memory Disorders Program, and a preliminary screening process will be performed over the phone. All potential subjects would be sent an informed consent document to look at before reviewing it with the study coordinator. Once they arrive at their initial visit, the research registry and its optional substudy (a postmortem exam available to all Cedars-Sinai patients) would be discussed with unlimited time for questions. If the subject, or his/ her surrogate decision maker (legally authorized representative, or LAR), consents to research, then his/ her clinical test results and (if applicable) the results of the postmortem exam will be kept on file for research purposes. If the subject/LAR consents, he/ she may also be contacted about any future research studies for which he/ she may be eligible. Patients who elect not to participate in this research will not be contacted for future studies. However, for those who are found to be ineligible and would like to learn about future studies as they arise, the Memory Disorders ICF offers them the option to be contacted in the future as new studies become available to them.

This research study will involve no collaborations, inside or outside of the Cedars-Sinai Medical Center. However, the subject's clinical care will involve collaborations with other departments within Cedars-Sinai Medical Center.

This registry will not involve any research-related costs, or any remunerative incentive.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
The main Memory Disorders Registry only involves records-keeping to follow subjects' care, and does not involve any biospecimen collection. The optional postmortem exam (brain-only autopsy) obtains brain tissue, and it would be performed after death, so that no risks will impact the subject involved in the postmortem examination. With regard to cosmetic concerns, the incision is made from ear to ear through the neck region, leaving no disfiguration. The postmortem exam is not a genetic screen, but in rare instances it might find brain atrophy, although no specific inclusions. If found, the subject's family would be informed of this finding.
Sampling Method Non-Probability Sample
Study Population The Registry's study population will consist of private patients of Dr. Robert Cohen who have been diagnosed with a Memory Disorder or who are referred to him due to subjective reports of having a memory problem.
Condition
  • Dementia
  • Alzheimer's Disease
  • Parkinson Disease
  • Huntington Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2012)
12
Original Estimated Enrollment
 (submitted: April 3, 2008)
600
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Capable of providing informed consent and having a legal representative able to consent out of concern for future competency to consent (as defined by a Mini Mental State Exam score of <24) or capable of assent but incapable of giving competent informed consent, but with a legal representative able to provide informed consent
  • Subject or family voices concern about their memory or possess knowledge that they have been diagnosed with a memory disorder such as Age Associated memory Impairment, Alzheimer's disease, Parkinson disease, Huntington disease, vascular dementia, mixed dementia, dementia with Lewy Bodies, or frontotemporal dementia

Exclusion Criteria:

  • Children (less than 18 years of age)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00654563
Other Study ID Numbers IRB12126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Robert Cohen, Ph.D., M.D., Cedars-Sinai Medical Center
Study Sponsor Cedars-Sinai Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Robert Cohen, Ph.D., M.D. Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date March 2012