Brief Summary

There are guidelines on the management of AD in China, the evidence adopted in the guidelines are mostly from the trials conducted in other countries due to very limited Chinese data available for local systematic review. Therefore, more local evidence on dementia care is needed for the development of an evidence-based guideline appropriate for people living in China. Meanwhile, the inadequate implementation of the current AD guideline, which results in the low diagnostic rate and high diagnostic leakage, may bring about extra barriers for AD patients to access dementia care service in different areas nationwide. However, there is no data on the clinical pathway about how physicians follow the dementia guideline in the routine practice. Therefore, research is needed to learn clinical diagnostic process and treatment patterns of physicians to people with AD in routine practice and help address the low accurate rate of AD clinical diagnosis and low anti-dementia drug prescription in the real world and support guideline development.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,024

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach

1 country

28 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

5 months study duration

Study Start

First participant enrolled

November 1, 2012

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed

Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

January 24, 2013

Last Update Submit

July 22, 2017

Conditions

Mild Cognitive Impairment Alzheimer's Disease Dementia

Outcome Measures

Primary Outcomes (1)

Rate of cognitive assessment administration
rate of cognitive assessment administration for diagnosing dementia
2 months

Secondary Outcomes (1)

Rate of anti-dementia prescription
2 months

Other Outcomes (1)

compliance rate of anti-dementia prescription
2 months

Study Arms (1)

Alzheimer's disease

Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are enrolled.

Eligibility Criteria

Age45 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are registered.

You may qualify if:

Male and female outpatients with clinically significant cognitive impairment per independent judgment of participating physicians;
Aged 45 year old and above;
Willing to receive 2 follow-up visits;
Having at least one informant or caregiver accompanying during each visit;
Willing to join the study and sign the informed consent prior to the study.

You may not qualify if:

Cognitive impairment is likely or identified as secondary to other disease condition(s) than AD (including but not limited to stroke, Parkinson's disease, brain trauma, central nervous system infection, etc.)
Unwilling to participate in the study;
Participating other studies during the registry study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Universitylead
Beijing Novartis Pharmacollaborator

Study Sites (28)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Anzhen Hospital, Capital Medical University