Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001480
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
The Evaluation and Follow-up of Individuals With Memory Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Evaluation and Follow-up of Patients With Memory Disorder and Normal Controls
Status:
COMPLETED
Status Verified Date:
2007-03-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate people with mild memory problems those with dementia those at risk for developing Alzheimers disease AD and healthy volunteers to identify markers of AD before the changes that occur with the disease begin
The origin and markers of progression for Alzheimers disease AD are relatively obscure Despite increased understanding of the underlying biology of AD its clinical diagnosis is still made only after progressive cognitive decline definitive diagnosis is confirmed at autopsy This study will examine biomarker changes over time in a distinct cohort of people with an increased risk of developing AD The study will also identify and track biological changes that occur with progressive dementia and compare those changes to the known cognitive and emotional disturbances that characterize AD
Individuals with a first-degree relative with AD will be recruited into an at-risk cohort They will be followed and compared to a group of healthy volunteers for a minimum of 8 years
The origin and markers of progression for Alzheimers disease AD are relatively obscure Despite increased understanding of the underlying biology of AD its clinical diagnosis is still made only after progressive cognitive decline definitive diagnosis is confirmed at autopsy This study will examine biomarker changes over time in a distinct cohort of people with an increased risk of developing AD The study will also identify and track biological changes that occur with progressive dementia and compare those changes to the known cognitive and emotional disturbances that characterize AD
Individuals with a first-degree relative with AD will be recruited into an at-risk cohort They will be followed and compared to a group of healthy volunteers for a minimum of 8 years
Detailed Description:
The temporal origin of Alzheimers disease AD and markers of progression of this disease process are relatively obscure Despite outstanding advances in the understanding of the underlying biology of AD the clinical diagnosis is still made by consensus following progressive cognitive deterioration and confirmed only at autopsy The protocol will serve two functions First we will evaluate and longitudinally follow a cohort of first-degree relatives of AD subjects who are currently normal but are at increased risk of developing AD sometime in the future This cohort will be compared to a group of normal controls along multiple behavioral cognitive motor function genetic and biologic parameters over a period of years While differential rates of conversion to AD might eventually be expected based on family history and other fixed variables ie APO E status this study is not powered to simply be a study of conversion to AD Rather it is a study of biomarker change over time in a distinct cohort of people with increased risk of developing AD Conversion to a clinical diagnosis of AD is only one of the variables others will include cognitive testing neuroimaging genetic markers assessment of functional capacities and cerebrospinal fluid CSF measures that may ultimately function as disease surrogates As part of this at risk cohort we will recruit and longitudinally follow a series of pre-symptomatic and symptomatic subjects with known genetic mutations presenilin 1 presenilin 2 or APP Second we will follow a large cohort of dementia subjects themselves for whom the diagnosis is either AD or some other related dementia The purpose of this second part of the follow-up study is to identify and track those biologic changes that occur with progressive illness and furthermore to relate those changes to the known cognitive and emotional disturbances which characterize AD
By longitudinally following separate cohorts of normal controls without a family history of AD normal controls with a family history of AD subjects with mild cognitive impairments and diagnosed dementia subjects we hope to track the spectrum of AD from its clinical and biologic origins As a result this study is both a diagnostic screening protocol and a natural history protocol It will address a series of important clinical and biological questions among a wide range of normal and diseased individuals and should serve as a basis for the development of biologic markers in AD that could be used for diagnostic and therapeutic purposes in the future A long-term goal of this protocol to identify markers and eventually individual people who are at increased risk of developing AD before the typical cognitive changes of AD become manifest In pursuit of that goal we will also carefully monitor and evaluate the clinical medications taken by our subjects to see if they influence the course of AD
By longitudinally following separate cohorts of normal controls without a family history of AD normal controls with a family history of AD subjects with mild cognitive impairments and diagnosed dementia subjects we hope to track the spectrum of AD from its clinical and biologic origins As a result this study is both a diagnostic screening protocol and a natural history protocol It will address a series of important clinical and biological questions among a wide range of normal and diseased individuals and should serve as a basis for the development of biologic markers in AD that could be used for diagnostic and therapeutic purposes in the future A long-term goal of this protocol to identify markers and eventually individual people who are at increased risk of developing AD before the typical cognitive changes of AD become manifest In pursuit of that goal we will also carefully monitor and evaluate the clinical medications taken by our subjects to see if they influence the course of AD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-M-0096 | None | None | None |