Mild Cognitive ImpairmentNCT01779310
Clinical Pathway for Alzheimer's Disease in China (CPAD)
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Peking University at 28 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease, Dementia
- How many people
- 1,024 participants
- Where
- 28 sitesChina
- Study dates
- Nov 2012to Apr 2013
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are registered.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Shijitan Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, Beijing Municipality
Peking University First Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Peking University Sixth Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
Mental Health Center, West China Hospital, Sichuan University
Chengdu, Sichuan
Guangzhou Brain Hospital
Guangzhou, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Shandong Mental Health Center
Jinan, Shandong
Shandong Provincial Hospital
Jinan, Shandong
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Nanjing Brain Hospital
Nanjing, Jiangsu
Ningbo Kangning Hospital
Ningbo, Zhejiang
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Shanghai Mental Health Center
Shanghai, Shanghai Municipality
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
The First Affiliated Hospital, Wenzhou Medical College
Wenzhou, Zhejiang
Union Hospital Tongji Mecial College, Huazhong University of Science and Technology
Wuhan, Hebei
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, Shaanxi
About this study
Official title: Clinical Pathway for Alzheimer's Disease in China (CPAD): A 8-week Multi-center Registry Study to Investigate AD Diagnostic Pattern in Chinese Local Real Clinical Practice
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.
Read the detailed description
Outpatients who are visiting memory clinics and who are judged by physicians with clinically significant cognitive impairment will be invited to join the study during the study recruiting period (with informed consent signed).
- Patients enrolled into the study will be evaluated and diagnosed by participating physicians and may or may not be prescribed with therapy (pharmaceutical and/or non-pharmaceutical) based on physicians' medical judgment.
- For patients with routine clinical follow-up visits, their medical charts will be reviewed for documentation. The procedures of making diagnosis and developing treatment scheme will be retrieved and documented in clinical report form (CRF). Additional procedures ordered by the participating physician at current visits will also be documented in CRF.
All participants will be followed twice after baseline visit to re-evaluate and confirm the initial diagnosis (where applicable), and to record compliance to treatment scheme, including the process of medication titration.
This study does not recommend nor restrict any specific treatments.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease, Dementia
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease | Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cognitive assessment administration
rate of cognitive assessment administration for diagnosing dementia
Measured: 2 months
Secondary outcomes (1)
Rate of anti-dementia prescription
rate of anti-dementia prescription for people with dementia
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,024 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Novartis Pharma
- Responsible party
- Principal investigator, Huali Wang, Peking University
- Investigators
- Huali Wang, MD/PhD, Principal investigator, Peking University Institute of Mental Health (Sixth Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779310
- Sponsor's protocol ID
- CENA731DCN01T
- Status last verified
- Jul 2017
- First submitted
- 24 Jan 2013
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pathway for Alzheimer's Disease in China (CPAD): A 8-week Multi-center Registry Study to Investigate AD Diagnostic Pattern in Chinese Local Real Clinical Practice
- ClinicalTrials.gov ID
- NCT01779310
- Acronym / sponsor ID
- CENA731DCN01T
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Beijing Novartis Pharma
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Outpatients who are visiting memory clinics and who are judged by physicians with clinically significant cognitive impairment will be invited to join the study during the study recruiting period (with informed consent signed).
- Patients enrolled into the study will be evaluated and diagnosed by participating physicians and may or may not be prescribed with therapy (pharmaceutical and/or non-pharmaceutical) based on physicians' medical judgment.
- For patients with routine clinical follow-up visits, their medical charts will be reviewed for documentation. The procedures of making diagnosis and developing treatment scheme will be retrieved and documented in clinical report form (CRF). Additional procedures ordered by the participating physician at current visits will also be documented in CRF.
All participants will be followed twice after baseline visit to re-evaluate and confirm the initial diagnosis (where applicable), and to record compliance to treatment scheme, including the process of medication titration.
This study does not recommend nor restrict any specific treatments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease | – | –Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are enrolled. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are registered.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of cognitive assessment administration
Time frame: 2 months
rate of cognitive assessment administration for diagnosing dementia
1 secondary outcome
Rate of anti-dementia prescription
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huali Wang, MD/PhD principal investigator
Peking University Institute of Mental Health (Sixth Hospital)
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Peking University at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cognitive assessment administration (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.