Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment no intervention
Sponsor Janssen Research & Development, LLC
Start date March 2014
End date March 2018
Trial size 1200 participants
Trial identifier NCT02114372, CR104383, REGISTRYALZ0001, RRA-11823

Summary

The purpose of this study is to investigate the natural history of cognitive and functional changes in participants at risk for developing mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (MCI-AD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective
Arm
The high risk cohort includes participants whose age- and education-adjusted baseline cognitive performance is -0.6 to -1.0 standard deviation (SD) below normal on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index and -0.6 to -1.5 SD below normal on at least one other nonmemory RBANS cognitive domain one other cognitive domain.
no intervention
This is an observational study that does not include the use of any specific treatments. Participants enrolled will undergo neuropsychological evaluations over a 4 year period to characterize patterns of cognitive and functional change.
The medium risk amnestic cohort included participants whose age- and education adjusted baseline cognitive performance is 0.6-1.0 SD below normal on the RBANS Delayed Memory Index and all other RBANS nonmemory domains within normal limits operationally defined as greater than -0.6 SD.
no intervention
This is an observational study that does not include the use of any specific treatments. Participants enrolled will undergo neuropsychological evaluations over a 4 year period to characterize patterns of cognitive and functional change.
The medium risk nonamnestic cohort included participants whose age- and education adjusted baseline cognitive performance is greater than -0.6 SD below normal on the RBANS Delayed Memory Index and one or more other RBANS domains are between -0.6 to -1.0 SD below normal.
no intervention
This is an observational study that does not include the use of any specific treatments. Participants enrolled will undergo neuropsychological evaluations over a 4 year period to characterize patterns of cognitive and functional change.
The low risk cohort included participants whose age- and education-adjusted baseline cognitive profile on the RBANS is within normal limits, as defined for this study as all RBANS domains greater than -0.6 SD below normal.
no intervention
This is an observational study that does not include the use of any specific treatments. Participants enrolled will undergo neuropsychological evaluations over a 4 year period to characterize patterns of cognitive and functional change.
The medium risk cohort included participants whose age- and education-adjusted baseline cognitive performance is 0.6-1.0 SD below normal on the RBANS Delayed Memory Index.
no intervention
This is an observational study that does not include the use of any specific treatments. Participants enrolled will undergo neuropsychological evaluations over a 4 year period to characterize patterns of cognitive and functional change.

Primary Outcomes

Measure
Change from baseline cognition
time frame: Up to 4 years

Eligibility Criteria

Male or female participants from 60 years up to 72 years old.

Inclusion criteria: - Enrolled in the CHARIOT Register - Willing and able to give written informed consent - Meets the definition for inclusion in the low risk, medium risk, or high risk cohorts according to criteria specified in the protocol Exclusion Criteria: - Concurrent participation in a clinical trial - Diagnosis of Dementia - Past or current use of memantine or cholinesterase inhibitors - Diagnosis of other neurologic disease or conditions known to cause or be associated with dementia, such as Parkinson's disease - History of traumatic brain injury with residual neurological deficit or stroke

Additional Information

Official title Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort Study (PRO)
Description This is a prospective single center study that will enroll participants without dementia who are considered at high, medium and low risk for developing mild cognitive impairment (MCI) due to Alzheimer's disease (AD) from a community-based register (referred to as the CHARIOT registry) in the United Kingdom. No interventions (ie, study drugs) will be administered to participants in the study. The planned duration of the study is approximately 4 years with up to 2 years for participant recruitment. Data collection to assess outcome measures associated with disease progression will occur at baseline and every 6 months thereafter at the clinic during the follow-up period of 48 months. Blood, urine, and saliva samples will be collected from participants during the study for biomarker analyses to assess risk factors for dementia, Alzheimer's disease or confounding factors of dementia risk. Adverse events experienced by the participants during their participation in the study will be monitored.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.