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Completed

NCT Number: NCT02501876

Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vall d´Hebron University Hospital

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

There is a retrospectiv observational study. No intervention

Other

There is a retrospectiv observational study. No intervention will be performed

Primary outcomes

  1. The rate of conversion to Alzheimer's disease (AD)

    Time frame: 6 months

Secondary outcomes

  1. The presence of common alleles for Alzheimer's disease (AD) and Diabetes mellitus type 2

    Time frame: 4 months

    The genetic role in the risk of conversion to AD and Diabetes mellitus type 2

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: DIACEA

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 17, 2015
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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