- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654563
Memory Disorders Registry
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Cohen, Ph.D., M.D., Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Tauopathies
- Cognition Disorders
- Chorea
- Parkinson Disease
- Alzheimer Disease
- Huntington Disease
- Memory Disorders
Other Study ID Numbers
- IRB12126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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