An evaluation of potential therapies to inhibit cerebral emboli in dementia - Therapies to inhibit cerebral emboli in dementia

Phase 1

• Conditions: Alzheimer's Disease and Vascular Dementia

• Registration Number: EUCTR2005-004283-23-GB
• Lead Sponsor: South Manchester University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

. Dementia - patients must fulfill DSM IV criteria for dementia (Diagnostic and Statistic Manual of Mental Disorders 1995)
. AD - patients must fulfill the NINCDS-ADRDA criteria (McKhann G et al 1984)
. VaD - patients must fulfill the NINCDS-AIREN criteria (Roman G D et al 1993)
. Patient must have an identified carer who can manage any trial medication

Controls:

No evidence of cognitive impairment or any other significant health impairment which might interfere with their participation.

American Psychiatric Association. Diagnoswtic and Statistical Manual of Mental Disorders. 1995. Fourth Edition. AMA, Washington DC.

McKhann G et al. Clinical Diagnosis of Alzheimer's disease: Report of the NINCSA-ADRDA work Group under the auspices of the Department of Health and Human Services Task Force of Alzheimer's disease. Neurology 1984;34:939-944.

Roman GD et al. Vascular dementia: Diagnostic criteria for research studies. Report of the NINDS-Airen International Workshop. Neurology 1993;43(February):250-260.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. Patients with a Mini-Mental State Examination (MMSE) (Folstein et al 1975, Molloy et al 1991) score of <10 and/or severe aphasia (as the study requires considerable co-opoeration)
. Current anticoagulant treatment (may reduce spontaneous emboli)
. Diagnosed as suffering from AF

Folstein MF, Folstein SE, McHugh PR. Mini-mental state. A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research 1975 Nov;12(3):189-98

Molloy DW, Alemayehu E, Roberts R. A standardised Mini-Mental State Examination (MMSE). American Journal of Psychiatry 1991;148 p102-105.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified