NCT02694445

Brief Summary

The purpose of the study is to estimate the Chinese economic burden in patients with Alzheimer's Disease (AD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,098

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

February 24, 2016

Results QC Date

April 8, 2020

Last Update Submit

May 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Annual National Total Socioeconomic Cost for All AD Patients in China

    The annual national total socioeconomic cost for all patients with AD in China in 2015 was obtained, with the average annual cost per patient with AD from our results multiplied by the all number of patients with AD in 2015. So, the value reported in the data table below represents the total cost for all all participants in China.

    one year

Interventions

The study is non-interventional.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Alzhemer's disease and their caregivers.

You may qualify if:

  • New patients who are diagnosed with AD in this investigation or old patients who were diagnosed prior to this investigation were eligible;
  • AD diagnosis must meet criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). The diagnosis should also meet the following: Modified Hachinski Ischemic Scale (MHIS) score≤4, Activity of Daily Living Scale (ADL) score≥23, Geriatric Depression Scale (GDS) score\<11. Neuroimaging MRI support AD diagnosis (exist atrophy in medial temporal lobe, white matter lesions score≤2 minutes according to the Fazekas criteria. AD disease classification according to mini-mental state examination (MMSE) scale (for illiterate dementia: mild: 21\~24 points; moderate: 11\~20 points; severe: 10 points or less; for lettered dementia: mild: 16\~19 points; moderate: 8\~15 points; severe: 7 points or less). The diagnosis of AD was confirmed by brain CT or MRI scans and by laboratory tests to rule out any other significant comorbidity.
  • year-old and above, men or women.
  • Normal vision or corrected visual, normal audition or corrected auditory, and cooperate with inspections and treatments.
  • Consent to participate with a signed informed consent by himself/herself or guardians.

You may not qualify if:

  • Patient with vascular dementia or dementia caused by other reasons, such as major depression or other major psychiatric illnesses, thyroid dysfunction, encephalitis, multiple sclerosis, and other dementia which includes frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and Parkinson's dementia (PDD).
  • MRI and laboratory tests (blood cell counts, liver and renal function, electrolyte, vitamin B12/folic, HIV, syphilis, and so on) do not support or rule out AD diagnoses.
  • Has a history of alcoholism and drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

  • Li F, Chen S, Wei C, Jia J. Monetary costs of Alzheimer's disease in China: protocol for a cluster-randomised observational study. BMC Neurol. 2017 Jan 25;17(1):15. doi: 10.1186/s12883-017-0802-9.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Results Point of Contact

Title
Jianping Jia
Organization
Department of Neurology, Xuan Wu Hospital,Beijing,China

Study Officials

  • Jia Jianping, Doctor

    Head of Neurology Department, Capital Medical University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2016

First Posted

February 29, 2016

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

May 12, 2020

Results First Posted

May 12, 2020

Record last verified: 2020-05

Locations