Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease

Study Overview
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Brief Summary
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In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes and or the presence of its related genes favors the conversion of MCI to AD.

Detailed Description
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In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, ie regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes favors the conversion of MCI to AD. We propose a case-control study comparing a group of 110 diabetic patients and a group of 110 non-diabetic patients with MCI matched by age, sex and cardiovascular risk factors. The main objective is the conversion to AD between the groups and if DM-2 is an independent risk factor. The secondary objective is to investigate whether genetic mechanisms related both to AD and DM-2 are associated with the increased risk of AD in diabetic patients. We will analyze 10 genes simultaneously associated with an increased risk of diabetes and / or its complications and AD.

Official Title
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Type 2 Diabetes Mellitus as Accelerator for the Progression to Alzheimer's Disease in Patients With Mild Cognitive Impairment

Conditions
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Alzheimer´s Disease, Diabetes Mellitus Type 2

Intervention / Treatment
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* Other: There is a retrospectiv observational study. No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of MCI using the NBACE neuropsychological tests battery. Age >65 years. At least two years follow-up. 110 subjects with type 2 diabetes 110 subjects without diabetes written informed consent. Exclusion Criteria: patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale Fazekas (escor˃2)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2D-MCI<br>110 MCI subjects with type 2 diabetes. There is a retrospectiv observational study. No intervention will be performed. | Other: There is a retrospectiv observational study. No intervention<br>* There is a retrospectiv observational study. No intervention will be performed<br>|
| nonT2D-MCI<br>110 MCI subjects without diabetes. There is a retrospectiv observational study. No intervention will be performed. | Other: There is a retrospectiv observational study. No intervention<br>* There is a retrospectiv observational study. No intervention will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of conversion to Alzheimer's disease (AD) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of common alleles for Alzheimer's disease (AD) and Diabetes mellitus type 2 | The genetic role in the risk of conversion to AD and Diabetes mellitus type 2 | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The risk of progession, patients