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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00299676




Registration number
NCT00299676
Ethics application status
Date submitted
3/03/2006
Date registered
7/03/2006
Date last updated
23/05/2014

Titles & IDs
Public title
An Observational Study of the Safety and Effectiveness of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period
Scientific title
An Observational Study of Clinical Outcomes and Safety Profile of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period
Secondary ID [1] 0 0
CR004816
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia 0 0
Galantamine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Galantamine (Reminyl)

001 - Galantamine (Reminyl) Use of Reminyl according to approved NZ data sheet


Treatment: Drugs: Galantamine (Reminyl)
Use of Reminyl according to approved NZ data sheet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting.
Timepoint [1] 0 0
Baseline, month 3, month 6, month 12 and month 18.
Secondary outcome [1] 0 0
Development of information regarding treatment expectations that can be used for communicating with patients and supporters.
Timepoint [1] 0 0
Baseline, month 3, month 6, month 12 and month 18.
Secondary outcome [2] 0 0
Gain usage experience in a clinical practice setting that can be used for communicating treatment expectations to patients and carers.
Timepoint [2] 0 0
Baseline, month 3, month 6, month 12 and month 18.

Eligibility
Key inclusion criteria
* Patients prescribed with galantamine according to the approved New Zealand Data Sheet
* The clinical decision to prescribe Galantamine must have been made before and independently of the decision to enroll the patient in this observational study
* The patient should not have commenced Galantamine treatment before the baseline visit
* Patients must be currently living at home (i.e. not in permanent residential care)
* Availability of a supporter who has regular contact with the patient
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients having known hypersensitivity to Galantamine
* Having severe liver impairment or severe kidney impairment
* Suffering from an uncontrolled medical condition other than dementia
* Being treated, or previously treated, with another cholinesterase inhibitor or other cholinomimetics (medications for treating Alzheimer's disease)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Auckland
Recruitment hospital [2] 0 0
- Christchurch Nz
Recruitment hospital [3] 0 0
- Hamilton
Recruitment hospital [4] 0 0
- Porirua
Recruitment hospital [5] 0 0
- Tauranga
Recruitment postcode(s) [1] 0 0
- Auckland
Recruitment postcode(s) [2] 0 0
- Christchurch Nz
Recruitment postcode(s) [3] 0 0
- Hamilton
Recruitment postcode(s) [4] 0 0
- Porirua
Recruitment postcode(s) [5] 0 0
- Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00299676
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00299676