NCT00299676

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2005

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

2.8 years

First QC Date

March 3, 2006

Last Update Submit

May 22, 2014

Conditions

Alzheimer DiseaseDementiaGalantamine

Keywords

Alzheimer's DiseaseDementiaPost MarketingProspective StudiesLongitudinal StudiesNew ZealandCholinesterase InhibitorsObservationalOutcomes

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • 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.

    Baseline, month 3, month 6, month 12 and month 18.

Study Arms (1)

001

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

Drug: Galantamine (Reminyl)

Interventions

Galantamine (Reminyl)DRUG

Use of Reminyl according to approved NZ data sheet

001

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Alzheimer's disease, who are currently not in permanent residential care. A convenience sampling method was applied.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Auckland, Australia

Location

Unknown Facility

Christchurch Nz, Australia

Location

Unknown Facility

Hamilton, Australia

Location

Unknown Facility

Porirua, Australia

Location

Unknown Facility

Tauranga, Australia

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Janssen-Cilag Pty Ltd Clinical Trial

    Janssen-Cilag Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 7, 2006

Study Start

May 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations

AU(5)