NCT01351961

Brief 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. This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the evolution of cognitive function and dementia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

April 22, 2011

Last Update Submit

September 9, 2025

Conditions

Keywords

HypertensionCognitive function

Outcome Measures

Primary Outcomes (1)

  • Global memory, visual retention and verbal fluency composite score

    up to two years

Secondary Outcomes (2)

  • vascular exploration

    up to two years

  • white matter hyperintensities by fazekas score.

    up to two years

Study Arms (1)

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

Biological: blood samplingProcedure: brain MRI and TEP cerebralOther: Assessment of cognitive functionsOther: Electrocardiogram and blood pressureProcedure: Vascular explorationsBiological: Urine sample

Interventions

blood samplingBIOLOGICAL

take a sample of blood, 46 ml

Elderly hypertensive patients with mnemonic subjective

magnetic resonance imaging

Elderly hypertensive patients with mnemonic subjective

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 .

Elderly hypertensive patients with mnemonic subjective

Electrocardiogramm Blood pressure monitoring

Elderly hypertensive patients with mnemonic subjective

Pulse wave velocity, VWF, IMT

Elderly hypertensive patients with mnemonic subjective
Urine sampleBIOLOGICAL
Elderly hypertensive patients with mnemonic subjective

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patient who have participated Adelahyde 1 study
  • patient who have signed a consent
  • patient who have a social security

You may not qualify if:

  • patient who can't understand information letter and who is not under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Nancy

Nancy, 54500, France

Location

Related Publications (1)

  • 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.

    PMID: 28279605BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionHypertension

Interventions

Blood Specimen CollectionBlood Pressure

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesVital SignsPhysical ExaminationHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Athanase BENETOS, professor

    CHU NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

April 22, 2011

First Posted

May 11, 2011

Study Start

April 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations