Completed

DIACEAInfluence of Type 2 Diabetes on Progression to Alzheimer's Disease in Mild Cognitive Impairment Patients

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Study Aim

This observational study aims to examine how Type 2 Diabetes influences the progression to Alzheimer's Disease in individuals with Mild Cognitive Impairment, focusing on the rate of conversion to Alzheimer's.

What is being collected

Data Collection

DNA Samples
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 65 to 90 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2015
See protocol details

Summary

Principal SponsorHospital Universitari Vall d'Hebron Research Institute
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2015

Actual date on which the first participant was enrolled.

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 TitleType 2 Diabetes Mellitus as Accelerator for the Progression to Alzheimer's Disease in Patients With Mild Cognitive Impairment
NCT02501876
Principal SponsorHospital Universitari Vall d'Hebron Research Institute
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

202 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 65 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate
110 subjects without diabetes

diagnosis of MCI using the NBACE neuropsychological tests battery.

Age >65 years.

At least two years follow-up.

Show More Criteria

1 exclusion criteria prevent from participating
patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale Fazekas (escor˃2)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Vall d´Hebron University Hospital

Barcelona, SpainOpen Vall d´Hebron University Hospital in Google Maps
CompletedOne Study Center