Alzheimer´s DiseaseDIACEANCT02501876
Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease
An observational study of Alzheimer´s Disease and Diabetes Mellitus Type 2, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Alzheimer´s Disease, Diabetes Mellitus Type 2
- How many people
- 202 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to May 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: A retrospective case-control study will be conducted in the Department of Endocrinology and Nutrition Hospital Vall d'Hebron, in collaboration with the department of Neurology and Laboratory. We will review the medical records and the complete neuropsychological evaluation of 110 subjects with MCI and DM-2 matched by age, sex, and cardiovascular risk factors with 110 non-diabetic subjects with MCI. We will select the patients (diabetic or non-diabetic) with a minimum follow-up of 2 years, and whose neuropsychological assessment has been performed using the battery NBACE to ensure a uniform evaluation criteria. In addition, only patients who have determined the ApoE genotype and those who have previously undergone brain MRI will be included.
Who may be able to join
- 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.
Who cannot join
- patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale Fazekas (escor˃2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Type 2 Diabetes Mellitus as Accelerator for the Progression to Alzheimer's Disease in Patients With Mild Cognitive Impairment
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.
Read the detailed 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.
- Conditions
- Alzheimer´s Disease, Diabetes Mellitus Type 2
- Being tested
- There is a retrospectiv observational study. No intervention
- Keywords
- The risk of progession, patients
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is a retrospectiv observational study. No interventionOther
There is a retrospectiv observational study. No intervention will be performed
| Study group | Role | What they receive |
|---|---|---|
| T2D-MCI | 110 MCI subjects with type 2 diabetes. There is a retrospectiv observational study. No intervention will be performed. Receives: Other: There is a retrospectiv observational study. No intervention | |
| nonT2D-MCI | 110 MCI subjects without diabetes. There is a retrospectiv observational study. No intervention will be performed. Receives: Other: There is a retrospectiv observational study. No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of conversion to Alzheimer's disease (AD)
Measured: 6 months
Secondary outcomes (1)
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer´s DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 202 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Simo Canonge, PhD, MD, Study director, VHIR Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501876
- Sponsor's protocol ID
- PR(AG)32/2015
- Acronym
- DIACEA
- Status last verified
- Apr 2017
- First submitted
- 16 Jul 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Espinosa A, Alegret M, Valero S, Vinyes-Junque G, Hernandez I, Mauleon A, Rosende-Roca M, Ruiz A, Lopez O, Tarraga 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.
PubMed 23271318
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Mellitus as Accelerator for the Progression to Alzheimer's Disease in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02501876
- Acronym / sponsor ID
- DIACEA / PR(AG)32/2015
- Conditions
- Alzheimer´s Disease, Diabetes Mellitus Type 2
- Keywords
- The risk of progession, patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2D-MCI | – | Other: There is a retrospectiv observational study. No intervention110 MCI subjects with type 2 diabetes. There is a retrospectiv observational study. No intervention will be performed. |
| nonT2D-MCI | – | Other: There is a retrospectiv observational study. No intervention110 MCI subjects without diabetes. There is a retrospectiv observational study. No intervention will be performed. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A retrospective case-control study will be conducted in the Department of Endocrinology and Nutrition Hospital Vall d'Hebron, in collaboration with the department of Neurology and Laboratory. We will review the medical records and the complete neuropsychological evaluation of 110 subjects with MCI and DM-2 matched by age, sex, and cardiovascular risk factors with 110 non-diabetic subjects with MCI. We will select the patients (diabetic or non-diabetic) with a minimum follow-up of 2 years, and whose neuropsychological assessment has been performed using the battery NBACE to ensure a uniform evaluation criteria. In addition, only patients who have determined the ApoE genotype and those who have previously undergone brain MRI will be included.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale Fazekas (escor˃2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is a retrospectiv observational study. No interventionThere is a retrospectiv observational study. No intervention will be performed | Other | T2D-MCI, nonT2D-MCI |
Primary outcome
The rate of conversion to Alzheimer's disease (AD)
Time frame: 6 months
1 secondary outcome
The presence of common alleles for Alzheimer's disease (AD) and Diabetes mellitus type 2
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Background: PubMed 23271318Espinosa A, Alegret M, Valero S, Vinyes-Junque G, Hernandez I, Mauleon A, Rosende-Roca M, Ruiz A, Lopez O, Tarraga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Simo Canonge, PhD, MD study director
VHIR Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer´s Disease and Diabetes Mellitus Type 2, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of conversion to Alzheimer's disease (AD) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.