Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke

Dementia Clinical Trial

— ASPIS  

Official title:

ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109836
• Other study ID #: DUK-2010-001
• Secondary ID: LS 09-002
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2010
• Last updated: January 12, 2015
• Start date: June 2010
• Est. completion date: November 2014

Study information

• Verified date: June 2010
• Source: Danube University Krems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health
• Study type: Interventional

Clinical Trial Summary

Aim of this randomized controlled study is to test if intensive polyintervention therapy including life style modifications targeting at reduction of modifiable risk factors of stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients receiving standard care.

Description:

Stroke is the second most frequent cause of death and cognitive deficits including dementia occur frequently following a stroke. The frequency of cognitive disturbances has been reported up to 30% and thus occurs three times more frequent than recurrent stroke (10%). Major attempts have been made to prevent the occurrence of new strokes by means of effective strategies including preventive drugs. In contrast, hardly any studies have been performed addressing the prevention of deteriorating cognitive function following a stroke. In spite of this high prevalence therapeutic possibilities are extremely limited. It must be expected that cognitive deficits become even a more frequent disability following stroke. This is caused by the increased aging of the population leading to further increase of incidence, furthermore that more people survive their acute stroke due to increased possibilities of acute treatment, and that frequent risk factors (e.g. hypertension, diabetes) are increasingly controlled, thus leading to less severe strokes with less severe and permanent motor deficits, but an increase of potentially disabling cognitive disturbances. The aim of this randomized controlled study is to test an intensive multiple intervention therapy for the first time in stroke and to add life style modifications targeting modifiable risk factors for cognitive deterioration.

It is hypothesized that the risk of post-stroke cognitive decline can be significantly reduced compared to a control group with standard care when using polyintervention. These interventions will focus on nutrition, exercise, cognitive and social activity and monitoring and management of metabolic and vascular risk factors. Regular contacts with the subjects shall increase motivation and adherence to the study protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Symptomatic ischemic stroke with clinical syndrome of stroke and a corresponding ischemic lesion.

• MRI or CT results compatible with clinical diagnosis of acute ischemic stroke

• NIH Stroke Scale Score on admission 1 to 14, both inclusive

• Modified Rankin Scale before stroke 0 to 2, inclusive

• Randomization within 3 months after stroke onset (goal: 80% within 3 weeks)

• Sufficient communication possible

• Informed consent given by the patient and/or the patient's legally acceptable representative

Exclusion Criteria:

• Substantial cognitive decline (Mini Mental State Examination (MMSE) score > 24) or pre-existing dementia or Parkinson disease

• Persistent disturbed level of consciousness

• Persistent aphasia

• Pre-existing significant psychiatric diseases (i.e. Schizophrenia, Major Depression, Bipolar Disorders, all according to DSMIV); Patients with minor Depression (DSM IV) can be included

• Severe sensory impairment making neuropsychological testing impossible

• Severe comorbidity (e.g. unstable or severe cardiovascular or pulmonal disease, neoplasm, severe liver or renal insufficiency and symptomatic stenosis of the ipsilateral carotid artery, cancer…)

• Unreliability for follow up

• Unwillingness or inability to participate or to sign the informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Decline
• Dementia
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Behavioral:
• Motivation and lifestyle intervention
Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.

Locations

Country	Name	City	State
Austria	Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig	Horn
Austria	Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer	Mauer bei Amstetten
Austria	Dept. Neurology, LK St.Pölten	St. Pölten
Austria	Dept of Neurology, Landesklinikum Donauregion Tulln	Tulln
Austria	Dept of Neurology, Landesklinikum Wr. Neustadt	Wr. Neustadt

Sponsors (2)

Lead Sponsor	Collaborator
Danube University Krems	NÖ Forschungs- und Bildungsges.m.b.H (NFB)

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of persons having cognitively declined at 24 months	Cognitive decline is defined as a significant decline in the composite scores of at least 2 of 5 neuropsychologically tested domains (speed of mental processing, executive functions, working memory, memory, spatial constructive functions). The alpha level for the decision is 0.05.	24 months after randomization	No
Primary	Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months	Difference between the measures at baseline and at 24 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).	24 months after randomization	No
Secondary	Number of persons having cognitively declined 12 months after randomization	Cognitive decline is defined as a significant decline in the composite scores of at least 2 of 5 neuropsychologically tested domains (speed of mental processing, executive functions, working memory, memory, spatial constructive functions). The alpha level for the decision is 0.05.	12 months after randomization	No
Secondary	Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months	Difference between the measures at baseline and at 12 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).	12 months after randomization	No
Secondary	Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months		12 months after randomization	No
Secondary	Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months		24 months after randomization	No
Secondary	Change in cognitive abilities measured by composite scores for each of 5 cognitive domains	For each of the five cognitive domains (executive functions, working memory, general memory, speed of cognitive processing, visual spatial ability) standardized composite scores are calculated from the differences between baseline and 12 months in individual neuropsychological test results.	12 months after randomization	No
Secondary	Composite outcome for vascular events	vascular events include recurrent stroke, ACS, bypass surgery, PTA and vascular death	24 months after randomization	Yes
Secondary	Neurological status on the National Institute of Health Stroke Scale (NIHSS) score		12 months after randomization	No
Secondary	Functional status on the modified Rankin Scale		12 months after randomization	No
Secondary	Activities of daily living on Barthel Index		12 months after randomization	No
Secondary	Quality of life on the EQ-5D		12 months after randomization	No
Secondary	Depression on the Center for Epidemiologic Studies Depression Scale (CESD)		12 months after randomization	No
Secondary	All cause mortality		24 months after randomization	Yes
Secondary	Change in cognitive abilities measured by composite scores for each of 5 cognitive domains	For each of the five cognitive domains (executive functions, working memory, general memory, speed of cognitive processing, visual spatial ability) standardized composite scores are calculated from the differences between baseline and 24 months in individual neuropsychological test results.	24 months after randomization	No
Secondary	Neurological status on the National Institute of Health Stroke Scale (NIHSS)score		24 months after randomization	No
Secondary	Functional status on the modified Rankin Scale		24 months after randomization	No
Secondary	Activities of daily living on Barthel Index		24 months after randomization	No
Secondary	Quality of life on the EQ-5D		24 months after randomization	No
Secondary	Depression on the Center for Epidemiologic Studies Depression Scale (CESD)		24 months after randomization	No