Mild Cognitive Impairment Clinical Trial
— CONCORDEOfficial title:
An Observational Study to Evaluate AD Conversion Rate Differences Between High-risk MCI and Low Risk MCI in Real World Setting
Verified date | May 2021 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
Eisai Korea Inc. |
Korea, Republic of,
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 |
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