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The purpose of this observational study is to investigate the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. not in permanent residential care), and to obtain information regarding usual clinical practice that can be used for communicating treatment expectations to patients and supporters.
This is a prospective, observational study to assess the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. not in permanent residential care), and to obtain information regarding usual clinical practice performed by relevant specialists. There will be no experimental component associated with this study and all observational activities will be part of routine care. This study will follow patients with Alzheimer's disease, who are currently not in permanent residential care, for a period of 18 months. The three domains of cognition, behavior and function will be evaluated at baseline using the Mini-Mental State Examination (MMSE) and/or ADAS-Cog, the abridged Instrumental Activities of Daily Living (IADL) and a 14-item behavioral assessment scale. Changes in the 3 domains will be observed after 3, 6, 12 and 18 months of Galantamine therapy through the completion of The Clinician Interview Based Impression of Change (CIBIC-Plus), abridged IADL, behavioral changes, and the Mini-Mental State Examination/ADAS-Cog. Primary outcome is to determine changes from baseline in cognition, behavior and function will be assessed after 3, 6, 12, and 18 months as measured by the CIBIC-Plus, abridged IADL, the Mini-Mental State Examination/ADAS-Cog and behavioral changes. The secondary outcome is development of information regarding treatment expectations that can be used for communicating with patients and supporters. Galantamine will be prescribed according to routine clinical practice and as per the Product Information leaflet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Galantamine (Reminyl) Use of Reminyl according to approved NZ data sheet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine (Reminyl) | Drug | Use of Reminyl according to approved NZ data sheet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting. | Baseline, month 3, month 6, month 12 and month 18. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of information regarding treatment expectations that can be used for communicating with patients and supporters. | Baseline, month 3, month 6, month 12 and month 18. | |
| Gain usage experience in a clinical practice setting that can be used for communicating treatment expectations to patients and carers. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Alzheimer's disease, who are currently not in permanent residential care. A convenience sampling method was applied.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Pty Ltd Clinical Trial | Janssen-Cilag Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland | Australia | |||||
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| Baseline, month 3, month 6, month 12 and month 18. |
| Christchurch Nz |
| Australia |
| Hamilton | Australia |
| Porirua | Australia |
| Tauranga | Australia |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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