NCT01423396

Brief Summary

Three quarters of patients with Alzheimer's disease have at least one vascular risk factor (VRF). Vascular brain lesions are present in most Alzheimer's patients (especially older ones). This cerebrovascular disease potentiates Alzheimer's lesions in early-stage disease. Many research studies have shown that VRFs are also risk factors for Alzheimer's disease; this is true for arterial hypertension and dyslipidaemia in particular and, to a lesser extent, diabetes and cardiopathy. Moreover, recent drug trials (SYST-EUR, PROGRESS and HOPE) have indicated that antihypertensive medications can prevent the appearance of dementia (and notably Alzheimer's disease) in over-60 hypertensive subjects. An observational study of 233 Alzheimer's patients with an average follow-up period of 4 years has shown that the annual decline in the Mini-Mental State Examination (MMSE) score was lower in patients in whom all the VRFs were being treated than in patients in whom no VRFs were being treated (1.5 ± 2.5 points versus 2.5 ± 2 points, respectively; p\<0.04).1 However, it is not currently known whether optimal treatment of VRFs can influence the progression and prognosis of Alzheimer's disease. Answering this question could have a significant impact on public health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

21 active sites

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

March 15, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

12.1 years

First QC Date

August 23, 2011

Last Update Submit

May 23, 2022

Conditions

Alzheimer's DiseaseCardiovascular Risk Factors

Keywords

Alzheimer's diseasecardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • ADAS-Cog

    18 months

Secondary Outcomes (9)

  • MMSE

    18 months

  • MoCA

    18 months

  • VADAS-Cog

    18 months

  • Trail Making Test

    18 months

  • ADL-ADCS

    18 months

  • +4 more secondary outcomes

Study Arms (2)

standard care

OTHER

Follow up with city doctor with recommendation HAS French guidelines

Other: standard care

optimal care of VRF

EXPERIMENTAL

Monitoring according to the strict recommendations of the HAS French guidelines

Other: optimal care of VRF

Interventions

optimal care of VRFOTHER

VRF of AD patients will be treated optimally in strict compliance with the French HAS guidelines concerning targets for blood pressure, glycaemia and blood lipid levels, in accordance with standardized therapeutic regimens.

optimal care of VRF
standard careOTHER

AD patients will be followed with the city doctor and the letter t will be send for remember French HAS guidelines

standard care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged 60 or over
  • Subjects with Alzheimer's disease, according to the NINCDS/ADRDA diagnostic criteria 71
  • MMSE \> 18
  • Subjects with at least one VRF (whether treated or not): arterial hypertension (defined as SBP/DBP ≥ 140/90 mmHg in at least three different consultations or, for ambulatory measurements, \> 130/80 mmHg with a Holter recorder or \> 135/85 mmHg with a self-measurement device), type 2 diabetes (defined as a glycaemia value over 1.26 g/l (7 mmol/l) after an 8-hour fast (confirmed on two occasions), dyslipidaemia (defined as an LDL cholesterol level \> 1.6 g/l or 1.3 or 1 g/l, depending on the patient's risk level)
  • Subjects having agreed to participate in the study (provision of informed consent).
  • Subjects accompanied by a person likely to provide information on the patient (during the visit or over the phone).

You may not qualify if:

  • Any other disease that might interfere with the evaluation of cognitive disorders.
  • No formal education or a poor understanding of French (interfering with administration of the neuropsychological tests).
  • Major physical problems likely to interfere with administration of the tests (poor eyesight, hearing, etc.).
  • Non-Alzheimer's dementia (isolated vascular dementia, Lewy body dementia, frontotemporal dementia, etc.)
  • Psychotropic drugs likely to modify the patient's non-stabilized cognitive state.
  • Patients with a history of cardiovascular events can be included (randomization will be balanced in terms of this criterion).
  • Participation in a therapeutic clinical trial during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Chu Amiens Picardie

Amiens, France

Location

CH ARRAS

Arras, France

Location

Centre Hospitalier Bethune Beuvry

Béthune, France

Location

CH Boulogne

Boulogne-sur-Mer, France

Location

Ch Calais -

Calais, France

Location

CH de DENAIN

Denain, France

Location

CH de DOUAI

Douai, France

Location

Ch Dunkerque

Dunkirk, France

Location

Ch Le Quesnoy

Le Quesnoy, France

Location

Ch Dr.Schaffner de Lens

Lens, France

Location

CMRR Lille hopital Roger Salengro

Lille, 59037, France

Location

Hôpital des Bâteliers, CHU

Lille, 59037, France

Location

CH Saint-Philibert, GHICL

Lomme, France

Location

Hu Paris Centre Site Broca Aphp - Paris

Paris, France

Location

CH de ROUBAIX

Roubaix, France

Location

Chu Rouen

Rouen, France

Location

Ch Region de St-Omer

Saint-Omer, France

Location

Groupe Hospitalier Seclin Carvin -

Seclin, France

Location

Chu de Bordeaux - Talence

Talence, 33404, France

Location

Ch Tourcoing

Tourcoing, France

Location

CH Valenciennes

Valenciennes, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Florence PASQUIER, MD

    Univ Lille Nord de France, clinique neurologique, Centre Mémoire de Ressources et de Recherche - CHRU Lille

    STUDY DIRECTOR

  • Marie-Anne MACKOWIAK, MD

    Univ Lille Nord de France, clinique neurologique, Centre Mémoire de Ressources et de Recherche - CHRU Lille

    PRINCIPAL INVESTIGATOR

  • Didier HANNEQUIN, MD

    CHU Rouen

    PRINCIPAL INVESTIGATOR

  • Olivier GODEFROY, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

  • Muriel RAINFRAY, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 25, 2011

Study Start

March 15, 2010

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(21)