Memory medication study: Alzheimer's Drug Duration - Impact on Functionality

Completed

• Conditions: Alzheimer?s Disease; Alzheimer's disease; Nervous System Diseases

• Registration Number: ISRCTN02733714
• Lead Sponsor: British Columbia Ministry of Health Services (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Policy criteria:
The patient is approved at least once for insurance coverage of ChEIs by British Columbia PharmaCare (the publicly financed drug benefit plan), meaning:
1.1. They are residents of British Columbia eligible for PharmaCare coverage
1.2. They are not in a hospital or long-term care institution (because drugs of such patients are mostly covered by the Health Authorities)
1.3. A physician has reported on a Special-Authority Request (insurance coverage application) form that the patient has a diagnosis involving Alzheimer's disease, and the severity of dementia was mild-to-moderate (scoring greater than 10 but less than 26 on the Standardised Mini-Mental Status Examination [SMMSE]) when they were first covered by PharmaCare

2. Clinical criteria:
At enrolment:
2.1. The patient has taken ChEIs for no longer than 12 months and has not used them for at least 12 months prior to that 12 months
2.2. The patient has tolerated ChEIs for at least 5 months but may have switched within that time due to intolerance of one type of ChEI
2.3. A physician has reported on a Special-Authority Request (insurance coverage application) form that the patient's Overall Patient Assessment Rating (OPAR), including assessments of cognition, function and behaviour, has neither improved nor seriously declined (i.e. 'indeterminate response', which means the difference in OPAR score is 0 or -1) by 6 to 12 months after starting the medications
2.4. Males and females included with no set age

3. Social-logistical criteria:
The personal caregiver (e.g. spouse or guardian) must be informed and consent as well as the patient. Therefore, the patient and caregiver:
3.1. Must speak English
3.2. Must be available by telephone
3.3. Must be willing to communicate by telephone with the Centre on Ageing. The patient's physician must also agree to their prescribing decisions being directed by a study protocol.

Exclusion Criteria

1. Non-Alzheimer-related dementia (for Special-Authority coverage, the diagnosis must be Alzheimer's disease, Alzheimer's disease with a vascular component, Alzheimer's disease with Lewy bodies or mixed dementia with predominant Alzheimer's disease)
2. Delay in recruitment of patients or their follow-up visit to their physician, so that they have taken ChEIs continuously for longer than 12 months prior to their availability to be randomised
3. Any use of ChEIs, even if brief, during the 12 months prior to the patient's most recent start of continuous use. However, patients who have used and stopped ChEIs more than 12 months before their most recent start of continuous use may be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physicians assessment of cognitive status and global assessment rating, measured at 6 months, 12 months, 18 months, 24 months.<br>

Secondary Outcome Measures

Name	Time	Method
1. Assessment of patients' cognitive status using Telephone Interview of Cognitive Status<br>2. Differences in caregiver assessments of the medications effectiveness<br>3. Incidence rates of health services use and use of other drugs using Ministry of Health Services central administrative databases<br>4. Net cost of health services using Ministry of Health Services central administrative databases and private expenses reported by caregivers in telephone interviews<br><br>Measured at 6 months, 12 months, 18 months, 24 months.