Evaluation of Vascular care in Alzheimer's disease
| ISRCTN | ISRCTN74902933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74902933 |
| Protocol serial number | NTR646 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 11/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W.A. Gool, van
Scientific
Scientific
Academic Medical Center (AMC)
Department of Neurology (H2-217)
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5664044 |
|---|---|
| w.a.vangool@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | EVA |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
Change in cognitive functioning, behavioral abnormalities, blood pressure, body weight. New lesions on MRI after two years. |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 130 |
| Key inclusion criteria | Patients with early Alzheimer's disease according to clinical criteria, that have on MRI either cerebral infarcts or significant white matter abnormalities. |
| Key exclusion criteria | 1. Severe dementia 2. Limited life expectancy |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No |
