A Study to Evaluate Alzheimer's Disease Conversion Rate Differences Between High-risk Mild Cognitive Impairment (MCI) and Low-risk MCI in a Real World Setting

Mild Cognitive Impairment Clinical Trial

— CONCORDE  

Official title:

An Observational Study to Evaluate AD Conversion Rate Differences Between High-risk MCI and Low Risk MCI in Real World Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448445
• Other study ID #: E0000-M082-603
• Status: Completed
• Start date: June 22, 2018
• Est. completion date: August 10, 2021

Study information

• Verified date: May 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will be conducted to evaluate the rate of Alzheimer's disease conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 89 Years

Eligibility

Inclusion Criteria:

• Participant over 55 years old and less than 90 years old
• Participant with subjective memory complaint by informant
• Clinical Dementia Rating (CDR) of 0.5; memory score box must be at least 0.5
• General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit
• Essentially preserved activities of daily living
• Absence of dementia
• Participant with Seoul Neuropsychological Screening Battery-Dementia Version cut-off score between 134.25 and 188.25
• Participants and caregivers who give written authorization to use their personal and health data
• Cognitive decline history within past 6 months from the baseline

Exclusion Criteria:

• Diagnostic evidence of probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association
• CDR-Global score (CDR-GS) >1
• Participant who has taken memantine, acetylcholinesterase inhibitors, or nootropics prior to participating in this study
• Any significant neurologic disease: other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
• Neuroimaging: participant with severe subcortical hyperintensities: D3-P3
• Magnetic resonance imaging exclusions: presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
• Participant who is pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Usual care setting
usual care settings without any intervention

Locations

Country	Name	City	State
Korea, Republic of	Eisai Trial site_12	Anyang
Korea, Republic of	Eisai Trial site_11	Busan
Korea, Republic of	Eisai Trial site_15	Busan
Korea, Republic of	Eisai Trial site_08	Changwon
Korea, Republic of	Eisai Trial site_09	Daegu
Korea, Republic of	Eisai Trial site_05	Daejeon
Korea, Republic of	Eisai Trial site_03	Gachon
Korea, Republic of	Eisai Trial site_07	Guri
Korea, Republic of	Eisai Trial site_10	Gwangju
Korea, Republic of	Eisai Trial site_16	Jeju
Korea, Republic of	Eisai Trial site_01	Seoul
Korea, Republic of	Eisai Trial site_02	Seoul
Korea, Republic of	Eisai Trial site_04	Seoul
Korea, Republic of	Eisai Trial site_06	Seoul
Korea, Republic of	Eisai Trial site_13	Seoul
Korea, Republic of	Eisai Trial site_14	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Alzheimer's Disease (AD) conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI	AD conversion differences will be assessed according to National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association Criteria for Probable AD.	Up to 36 months
Secondary	Mean change from Baseline in Seoul Neuropsychological Screening Battery-Dementia Version scores		Baseline, Month 12, Month 24
Secondary	Mean change from Baseline in Clinical Dementia Rating (CDR) Sum of Boxes scores		Baseline, Month 12, Month 24
Secondary	Mean change from Baseline in the CDR-Global Score		Baseline, Month 12, Month 24
Secondary	Mean change from Baseline in Geriatric Depression Scale scores		Baseline, Month 12, Month 24
Secondary	Mean change from Baseline in the volume of the whole brain according to Baseline demographics		Baseline, Month 12, Month 24
Secondary	Mean change from Baseline in other structural magnetic resonance imaging (MRI) measures according to Baseline demographics		Baseline, Month 12, Month 24
Secondary	Mean change from Baseline in the volume of the hippocampus according to Baseline demographics		Baseline, Month 12, Month 24