Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease

Diabetes Mellitus Type 2 Clinical Trial

— DIACEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501876
• Other study ID #: PR(AG)32/2015
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: April 11, 2017
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer´s Disease
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Spain	Vall d´Hebron University Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Espinosa A, Alegret M, Valero S, Vinyes-Junqué G, Hernández I, Mauleón A, Rosende-Roca M, Ruiz A, López O, Tárraga L, Boada M. A longitudinal follow-up of 550 mild cognitive impairment patients: evidence for large conversion to dementia rates and detection of major risk factors involved. J Alzheimers Dis. 2013;34(3):769-80. doi: 10.3233/JAD-122002. Erratum in: J Alzheimers Dis. 2015;43(1):335. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of conversion to Alzheimer's disease (AD)		6 months
Secondary	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