Monetary Cost of Alzheimer's Disease in China

• Sponsor: Beijing Friendship Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02694445
• Collaborator: Chinese Medical Doctor Association (Other)
• Enrollment: 3,098
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 442.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Other: observation

Detailed Description

This observational study covered all the 30 provincials/municipals/autonomous in mainland China except Hong Kong and Macau. Tier 3 hospitals, psychiatric hospitals, elderly hospitals, nursing home and communities were randomly selected as research centers, and more than 2500 patients with AD and their caregivers were enrolled at last. The main outcome of this study was assessed not only by the electronic medical system of communities and hospitals, but also by questionnaires. Using a societal prevalence-based gross COI approach to estimated the total yearly costs of AD in China.

Study Design

• Study Type: Observational
• Actual Enrollment: 3098 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Monetary Cost of Alzheimer's Disease in China: Study Protocol for a Cluster Randomized Observational Study
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. The Annual National Total Socioeconomic Cost for All AD Patients in China [one year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. New patients who are diagnosed with AD in this investigation or old patients who were diagnosed prior to this investigation were eligible；

2. 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.

3. 60-year-old and above, men or women.

4. Normal vision or corrected visual, normal audition or corrected auditory, and cooperate with inspections and treatments.

5. Consent to participate with a signed informed consent by himself/herself or guardians.

Exclusion Criteria:

1. 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).

2. 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.

3. Has a history of alcoholism and drug abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100053

Sponsors and Collaborators

• Beijing Friendship Hospital
• Chinese Medical Doctor Association

Investigators

• Study Chair: Jia Jianping, Doctor, Head of Neurology Department, Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianping Jia, Professor, Beijing Friendship Hospital
• ClinicalTrials.gov Identifier: NCT02694445
• Other Study ID Numbers: MAC-001
• First Posted: Feb 29, 2016
• Last Update Posted: May 12, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Arm/Group Title	Participant Patients
Arm/Group Description	Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
Period Title: Overall Study
STARTED	3098
COMPLETED	3046
NOT COMPLETED	52

Baseline Characteristics

Arm/Group Title	Participant Patients
Arm/Group Description	Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
Overall Participants	3046
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.24 (9.43)
Sex: Female, Male (Count of Participants)
Female	1651 54.2%
Male	1395 45.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
China	3046 100%

Outcome Measures

1. Primary Outcome

Title	The Annual National Total Socioeconomic Cost for All AD Patients in China
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participant AD Patients
Arm/Group Description	Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
Measure Participants	3046
Number [billion US$]	167.74

Adverse Events

Time Frame	All-cause mortality, serious, and other (not including serious) adverse events were not monitored/assessed.
Adverse Event Reporting Description	All-cause mortality, serious, and other (not including serious) adverse events were not monitored/assessed.
Arm/Group Title	Participant Patients
Arm/Group Description	Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
All Cause Mortality
	Participant Patients
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Participant Patients
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Participant Patients
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.