Condition category
Nervous System Diseases
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
11/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof W.A. Gool, van

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Neurology (H2-217)
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5664044
w.a.vangool@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR646

Study information

Scientific title

Acronym

EVA

Study hypothesis

Intensive vascular care, aimed at secondary prevention of cerebrovascular disease, is efficacious in patients with Alzheimer's disease that have vascular lesions on magnetic resonance imaging (MRI).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Alzheimer's disease

Intervention

Multicomponent intervention consisting of a combination of measures aimed at prevention of cerebrovascular disease (platelet aggregation inhibitors, statin, strict regulation of blood pressure, diabetes, life style interventions concerning smoking, body weight, exercise). Patients in the control group will receive 'regular care' i.e. less frequent visits, without specific attention to vascular risk factors.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in impairments after two years of follow up in activities of daily living as measured by the Interview for Deterioration in Daily life in Dementia (IDDD).

Secondary outcome measures

Change in cognitive functioning, behavioral abnormalities, blood pressure, body weight. New lesions on MRI after two years.

Overall trial start date

01/06/2002

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with early Alzheimer's disease according to clinical criteria, that have on MRI either cerebral infarcts or significant white matter abnormalities.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Severe dementia
2. Limited life expectancy

Recruitment start date

01/06/2002

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19484836

Publication citations

  1. Results

    Richard E, Kuiper R, Dijkgraaf MG, Van Gool WA, , Vascular care in patients with Alzheimer's disease with cerebrovascular lesions-a randomized clinical trial., J Am Geriatr Soc, 2009, 57, 5, 797-805.

Additional files

Editorial Notes