Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 12:13 AM
NCT ID: NCT02303158
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.
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.
Study: NCT02303158
Study Brief:
Protocol Section: NCT02303158