Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 12:26 PM
Study NCT ID:
NCT02303158
Status:
TERMINATED
Last Update Posted:
2018-10-09
First Post:
2014-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Protein Biomarkers in Cerebrospinal Fluid and Alzheimer&Apos;s Disease in Patients With Depression
Sponsor:
Institut Investigacio Sanitaria Pere Virgili
Organization:
Study Overview
Official Title:
Study of the Relationship Between Protein Biomarkers in Cerebrospinal Fluid and the Risk of Progression to Alzheimer&Apos;s Disease in a Cohort of Patients With Depression
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
futility of the sample
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIDEAL
Brief Summary:
It is currently accepted that depression during midlife is a risk factor for Alzheimer's disease (AD). Furthermore, several prospective population studies have demonstrated that depression is an independent risk factor for incident dementia of different types (e.g. vascular, mixed, Alzheimer's disease). However, it is not clear, what are the mechanisms that link depression and dementia, and if depression can be a prodromal manifestation of AD. There are also studies that suggest that depression could be an initial sign of AD.
Objective:
1. Demonstrate that late life depression (over 60 years of age) constitutes the first manifestation of AD.
2. Define by rating scales and life stressors have differential risk profiles evolutionary AD.
3. To study the relationship between the subtypes of depression and CSF biomarkers, neurophycological test and evolution to AD.
Objective:
1. Demonstrate that late life depression (over 60 years of age) constitutes the first manifestation of AD.
2. Define by rating scales and life stressors have differential risk profiles evolutionary AD.
3. To study the relationship between the subtypes of depression and CSF biomarkers, neurophycological test and evolution to AD.
Detailed Description:
Groups of subjects: patients with recent apparition of late life depression without fulfilling the dementia criteria (Global Deterioration Scale, GDS, stages 1, 2 and 3). A longitudinal, prospective population study with two years follow-up. A cohort of will be included in the study. The patient's depression will be defined and categorized according to its severity (Yesavage Scale), whether it's endogenous or reactive (Holmes and Rahe scale) and taking into account the patient's medical history of depression.
There will be a prospective follow-up of conversion to dementia (starting from GDS Stage 4). It will be considered that dementia corresponds to AD if the biological markers of LCR present typical changes of AD at the moment of inclusion (Beta amyloid low and P-tau high).
It will be studied if there's any correlation between the clinically defined depression types and a high risk of progression to dementia and especially to AD.
There will be a prospective follow-up of conversion to dementia (starting from GDS Stage 4). It will be considered that dementia corresponds to AD if the biological markers of LCR present typical changes of AD at the moment of inclusion (Beta amyloid low and P-tau high).
It will be studied if there's any correlation between the clinically defined depression types and a high risk of progression to dementia and especially to AD.
Study Oversight
Has Oversight DMC:
True
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?: