Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
970 participants
OBSERVATIONAL
2005-08-31
2011-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mild cognitive impairment or dementia
Patients with mild cognitive impairment or dementia.
Current treatment practice of each participating physician
Patients will be observed for the evaluation of current management strategies.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Current treatment practice of each participating physician
Patients will be observed for the evaluation of current management strategies.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Living in the community (home, apartment or collective housing with nursing care available for less than 40 hours per week)
* Patient able to provide written informed consent, or provision of written informed consent by a legal guardian/proxy
* Availability of a caregiver willing to provide consent for required components of the study
* Fluent in English
* May be participating in a Phase IV or other post-marketing follow up study of an approved product for treatment of dementia
Exclusion Criteria
* Not unwilling or unable to complete the study
* Not concurrently participating in a clinical trial of an investigational drug (phase I, II or III)
* Unwillingness of patient or legal guardian / proxy to provide written informed consent
* Unwillingness of caregiver to provide written informed consent
* For patients with diagnosis of mild cognitive impairment: current or previous treatment with any cholinesterase or memantine
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen-Cilag Pty Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen-Cilag Pty Ltd Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Pty Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chermside, , Australia
Fremantle, , Australia
Geelong, , Australia
Heidelberg, , Australia
Hornsby, , Australia
Kew, , Australia
Newcastle, , Australia
Randwick, , Australia
Woodville, , Australia
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Prospective Research in Memory Clinics (PRIME)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GALDEM4007
Identifier Type: OTHER
Identifier Source: secondary_id
CR004819
Identifier Type: -
Identifier Source: org_study_id