Cognitive ImpairmentADELAHYDE2NCT01351961
Vascular Alteration and Evolution of Cognitive Impairment
A study testing blood sampling, brain MRI and TEP cerebral and Assessment of cognitive functions in people with Cognitive Impairment, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
In the cross sectional study "Adelahyde 1" which took place between 2001 and 2005, the investigators data suggest that vascular alterations may play a role in the setting of subjective memory complaints. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- blood sampling, brain MRI and TEP cerebral and Assessment of cognitive functions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Nov 2013
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patient who have participated Adelahyde 1 study
- patient who have signed a consent
- patient who have a social security
Who cannot join
- patient who can't understand information letter and who is not under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Function and Structure and Evolution of Cognitive Impairment in Elderly Hypertensive Subjects With Subjective Memory Complaints
In the cross sectional study "Adelahyde 1" which took place between 2001 and 2005, the investigators data suggest that vascular alterations may play a role in the setting of subjective memory complaints.
This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the evolution of cognitive function and dementia.
Read the detailed description
Background: The role of arterial hypertension and vascular alterations in the development of cognitive decline is a major issue in both research and clinical practice. In a recently published cross-sectional study (Kearney-Schwartz, Rossignol et al. 2009), conducted on the "ADELAHYDE" cohort comprised of older hypertensive patients with memory complaints, the investigators showed the association of arterial changes (hypertrophy and arterial stiffness, endothelial dysfunction) with cognitive functions and/or white matter hyperintensities on MRI. A longitudinal study is the only means to confirm the role of vascular factors in the evolution of cognitive function and onset of dementia.
Objectives: i) Primary: To establish, in the "ADELAHYDE" cohort, the relationship between vascular alterations assessed at baseline during the cross-sectional study (hypertrophy and arterial stiffness, endothelial dysfunction) and the evolution of cognitive function (primary study endpoint) over a 8-year follow-up period; ii) Secondary a) To investigate the evolution of white matter hyperintensities on MRI (secondary study endpoint) as a function of peripheral vascular status, and especially of endothelial function. b) Determine the role of genetic factors and biomarkers of oxidative stress (from DNA and serum biobanks collected at the first visit) in the evolution of cognitive functions and white matter hyperintensities.
Methods: Prospective longitudinal single center study. All patients (378 subjects) who participated in the baseline cross-sectional study conducted between 2001 and 2005, will be reconvened at the Clinical Investigation Centre (CIC) of Nancy.
As in the cross-sectional study, the following will be assessed in this longitudinal phase: pulse wave velocity (PWV), carotid ultrasonography, flow-mediated dilation, brain MRI with semi-quantification of white matter hyperintensities, cognitive function evaluation and measurement of various biomarkers of endothelial function.
Expected fallouts: A major benefit of this project is that this cohort has already been explored in terms of cognitive function, arterial properties and neurovascular imaging (MRI). Thus, the programmed reconvening of these subjects for this project in 2011 will enable us to identify the role of vascular alterations in the evolution of cognitive function and leucoaraiosis in this population at high risk of dementia over a period of at least 8 years. Finally, it could pave the way for further investigations, notably in the field of cognitive impairment prevention, aimed at reducing or delaying the onset of dementia by acting on the "vascular factor", which is potentially modifiable.
- Conditions
- Cognitive Impairment
- Being tested
- blood sampling, brain MRI and TEP cerebral, Assessment of cognitive functions, Electrocardiogram and blood pressure, Vascular explorations
- Keywords
- Hypertension, Cognitive function
- Medical subject headings
- Cognitive Dysfunction, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
take a sample of blood, 46 ml
brain MRI and TEP cerebralProcedure or surgery
magnetic resonance imaging
Assessment of cognitive functionsOther
Folstein MMSE, Mac Nair scale, Depression (GDS) scale, The Benton Visual Retention Test, Test of verbal fluency, formal and categorical, Trail Making Test, Grober et Buschke scale (RL/RI-16), Apathy Robert scale, Praxis rating Scale .
Electrocardiogram and blood pressureOther
Electrocardiogramm Blood pressure monitoring
Vascular explorationsProcedure or surgery
Pulse wave velocity, VWF, IMT
Urine sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| Elderly hypertensive patients with mnemonic subjective | Other | Elderly hypertensive patients with mnemonic subjective without dementia. Interventions :
blood sampling brain MRI Assessment of cognitive functions brain MRI and TEP cerebral Electrocardiogram and blood pressure Pulse wave velocity Quality of life questionnaire Urine sample Vascular explorations Receives: Biological: blood sampling; Procedure: brain MRI and TEP cerebral; Other: Assessment of cognitive functions; Other: Electrocardiogram and blood pressure; Procedure: Vascular explorations; Biological: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global memory, visual retention and verbal fluency composite score
Measured: up to two years
Secondary outcomes (2)
vascular exploration
Pulse wave velocity, VWF, IMT
Measured: up to two years
white matter hyperintensities by fazekas score.
Hyperintensities of white matter will be classified following the Fazekas scale (6 ranks.
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2013
- Study completionNov 2013
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 Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Athanase BENETOS, Central Hospital, Nancy, France
- Investigators
- Athanase BENETOS, professor, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351961
- Sponsor's protocol ID
- 2010-A01399-30
- Acronym
- ADELAHYDE2
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2011
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferreira JP, Kearney Schwartz A, Watfa G, Zohra L, Felblinger J, Boivin JM, Bracard S, Hossu G, Verger A, Joly L, Zannad F, Rossignol P, Benetos A. Memory Alterations and White Matter Hyperintensities in Elderly Patients With Hypertension: The ADELAHYDE-2 Study. J Am Med Dir Assoc. 2017 May 1;18(5):451.e13-451.e25. doi: 10.1016/j.jamda.2017.01.008. Epub 2017 Mar 6.
PubMed 28279605
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Function and Structure and Evolution of Cognitive Impairment in Elderly Hypertensive Subjects With Subjective Memory Complaints
- ClinicalTrials.gov ID
- NCT01351961
- Acronym / sponsor ID
- ADELAHYDE2 / 2010-A01399-30
- Conditions
- Cognitive Impairment
- Keywords
- Hypertension, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 May 2011 (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 the cross sectional study "Adelahyde 1" which took place between 2001 and 2005, the investigators data suggest that vascular alterations may play a role in the setting of subjective memory complaints.
This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the evolution of cognitive function and dementia.
Detailed description
Background: The role of arterial hypertension and vascular alterations in the development of cognitive decline is a major issue in both research and clinical practice. In a recently published cross-sectional study (Kearney-Schwartz, Rossignol et al. 2009), conducted on the "ADELAHYDE" cohort comprised of older hypertensive patients with memory complaints, the investigators showed the association of arterial changes (hypertrophy and arterial stiffness, endothelial dysfunction) with cognitive functions and/or white matter hyperintensities on MRI. A longitudinal study is the only means to confirm the role of vascular factors in the evolution of cognitive function and onset of dementia.
Objectives: i) Primary: To establish, in the "ADELAHYDE" cohort, the relationship between vascular alterations assessed at baseline during the cross-sectional study (hypertrophy and arterial stiffness, endothelial dysfunction) and the evolution of cognitive function (primary study endpoint) over a 8-year follow-up period; ii) Secondary a) To investigate the evolution of white matter hyperintensities on MRI (secondary study endpoint) as a function of peripheral vascular status, and especially of endothelial function. b) Determine the role of genetic factors and biomarkers of oxidative stress (from DNA and serum biobanks collected at the first visit) in the evolution of cognitive functions and white matter hyperintensities.
Methods: Prospective longitudinal single center study. All patients (378 subjects) who participated in the baseline cross-sectional study conducted between 2001 and 2005, will be reconvened at the Clinical Investigation Centre (CIC) of Nancy.
As in the cross-sectional study, the following will be assessed in this longitudinal phase: pulse wave velocity (PWV), carotid ultrasonography, flow-mediated dilation, brain MRI with semi-quantification of white matter hyperintensities, cognitive function evaluation and measurement of various biomarkers of endothelial function.
Expected fallouts: A major benefit of this project is that this cohort has already been explored in terms of cognitive function, arterial properties and neurovascular imaging (MRI). Thus, the programmed reconvening of these subjects for this project in 2011 will enable us to identify the role of vascular alterations in the evolution of cognitive function and leucoaraiosis in this population at high risk of dementia over a period of at least 8 years. Finally, it could pave the way for further investigations, notably in the field of cognitive impairment prevention, aimed at reducing or delaying the onset of dementia by acting on the "vascular factor", which is potentially modifiable.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly hypertensive patients with mnemonic subjective | Other | Biological: blood sampling, Procedure: brain MRI and TEP cerebral, Other: Assessment of cognitive functions, Other: Electrocardiogram and blood pressure, Procedure: Vascular explorations, Biological: Urine sampleElderly hypertensive patients with mnemonic subjective without dementia. Interventions : blood sampling brain MRI Assessment of cognitive functions brain MRI and TEP cerebral Electrocardiogram and blood pressure Pulse wave velocity Quality of life questionnaire Urine sample Vascular explorations |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patient who have participated Adelahyde 1 study
- patient who have signed a consent
- patient who have a social security
Key exclusion criteria (1 listed)
- patient who can't understand information letter and who is not under legal protection
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 |
|---|---|---|
| blood samplingtake a sample of blood, 46 ml | Biological | Elderly hypertensive patients with mnemonic subjective |
| brain MRI and TEP cerebralmagnetic resonance imaging | Procedure or surgery | Elderly hypertensive patients with mnemonic subjective |
| Assessment of cognitive functionsFolstein MMSE, Mac Nair scale, Depression (GDS) scale, The Benton Visual Retention Test, Test of verbal fluency, formal and categorical, Trail Making Test, Grober et Buschke scale (RL/RI-16), Apathy Robert scale, Praxis rating Scale . | Other | Elderly hypertensive patients with mnemonic subjective |
| Electrocardiogram and blood pressureElectrocardiogramm Blood pressure monitoring | Other | Elderly hypertensive patients with mnemonic subjective |
| Vascular explorationsPulse wave velocity, VWF, IMT | Procedure or surgery | Elderly hypertensive patients with mnemonic subjective |
| Urine sample | Biological | Elderly hypertensive patients with mnemonic subjective |
Primary outcome
Global memory, visual retention and verbal fluency composite score
Time frame: up to two years
2 secondary outcomes
vascular exploration
Time frame: up to two years
white matter hyperintensities by fazekas score.
Time frame: up to two years
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 15 Sep 2025.
- Results publication: PubMed 28279605Ferreira JP, Kearney Schwartz A, Watfa G, Zohra L, Felblinger J, Boivin JM, Bracard S, Hossu G, Verger A, Joly L, Zannad F, Rossignol P, Benetos A. Memory Alterations and White Matter Hyperintensities in Elderly Patients With Hypertension: The ADELAHYDE-2 Study. J Am Med Dir Assoc. 2017 May 1;18(5):451.e13-451.e25. doi: 10.1016/j.jamda.2017.01.008. Epub 2017 Mar 6.
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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.
Athanase BENETOS, professor principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling, brain MRI and TEP cerebral and Assessment of cognitive functions in people with Cognitive Impairment, run by Central Hospital, Nancy, France at 1 site in France.
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 3 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 15 Sep 2025. 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 France. 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?
Global memory, visual retention and verbal fluency composite score (time frame: up to two years). 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 NCT01351961, 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 15 Sep 2025.