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

NCT03448445 | Completed

• 1 other identifier: E0000-M082-603
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

High-risk; Low-risk; Alzheimer's disease; Observational study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean change from Baseline in Seoul Neuropsychological Screening Battery-Dementia Version scores

  Baseline, Month 12, Month 24

• Mean change from Baseline in Clinical Dementia Rating (CDR) Sum of Boxes scores

  Baseline, Month 12, Month 24

• Mean change from Baseline in the CDR-Global Score

  Baseline, Month 12, Month 24

• Mean change from Baseline in Geriatric Depression Scale scores

  Baseline, Month 12, Month 24

• Mean change from Baseline in the volume of the whole brain according to Baseline demographics

  Baseline, Month 12, Month 24

Study Arms (2)

High-risk MCI

This cohort will include participants with high-risk mild cognitive impairment (MCI).

Other: Usual care setting

Low-risk MCI

This cohort will include participants with low-risk MCI.

Other: Usual care setting

Interventions

Usual care setting OTHER

usual care settings without any intervention

High-risk MCI; Low-risk MCI

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with mild cognitive impairment

You may qualify if:

• 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

You may not qualify if:

• 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
• Participant who is pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (16)

Eisai Trial site_12

Anyang, South Korea

Location

Eisai Trial site_11

Busan, South Korea

Location

Eisai Trial site_15

Busan, South Korea

Location

Eisai Trial site_08

Changwon, South Korea

Location

Eisai Trial site_09

Daegu, South Korea

Location

Eisai Trial site_05

Daejeon, South Korea

Location

Eisai Trial site_03

Gachon, South Korea

Location

Eisai Trial site_07

Guri-si, South Korea

Location

Eisai Trial site_10

Gwangju, South Korea

Location

Eisai Trial site_16

Jeju City, South Korea

Location

Eisai Trial site_01

Seoul, South Korea

Location

Eisai Trial site_02

Seoul, South Korea

Location

Eisai Trial site_04

Seoul, South Korea

Location

Eisai Trial site_06

Seoul, South Korea

Location

Eisai Trial site_13

Seoul, South Korea

Location

Eisai Trial site_14

Seoul, South Korea

Location

Related Publications (1)

• Jang H, Na DL, Kwon JC, Jung NY, Moon Y, Lee JS, Park KW, Lee AY, Cho H, Lee JH, Kim BC, Park KH, Lee BC, Choi H, Kim J, Park MY. A Two-Year Observational Study to Evaluate Conversion Rates from High- and Low-Risk Patients with Amnestic Mild Cognitive Impairment to Probable Alzheimer's Disease in a Real-World Setting. J Alzheimers Dis Rep. 2024 May 17;8(1):851-862. doi: 10.3233/ADR-230189. eCollection 2024.

  PMID: 38910942 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: June 22, 2018
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-05

Locations

KR (16)