| Cohort Name |
CHARIOT: PRO Main Study |
| Cohort Acronym |
CHARIOT: PRO |
| Study Overview |
There is limited information on people with minimal cognitive changes who are likely to progress to both the earliest stage of cognitive impairment due to Alzheimer’s disease (AD) and then clinically evident dementia of the Alzheimer’s type. Characterizing change in cognition is essential to identify opportunity for intervention at the earliest stage of disease. Participants in both the Main Study and the Substudy will undergo a series of neuropsychological evaluations to characterize the patterns of cognitive change and their inter-relationship in the earliest stages of cognitive impairment. In addition, how such changes relate to the clinical presentation of cognitive impairment of the Alzheimer’s type may be evaluated over time. An opportunity is possible to identify and characterize individuals with different likelihoods of progressing along different clinical paths, which may form a framework for the evaluation of interventions. |
| #Subjects at Baseline |
712 |
| Institution Name |
Imperial College London |
| Department Name |
Neuroepidemiology and Ageing Research Unit |
| City |
London |
| Principal Investigator (PI) |
Prof Lefkos Middleton |
| Population Based Study? |
Yes |
| Family Based Study? |
No |
| Clinical based sample? |
No |
| Is there follow-up data available? |
Yes |
| Were participants included prior to development of dementia (may refer to controls only)? |
Yes |
| Were participants included prior to development of MCI (may refer to controls only)? |
Yes |
| How is data collected? |
In person: 6-monthly visits to ICL site |
| Who carries out data collection? |
Interviewers, Clinicians. Clinical Staff: Research nurses, Assistant Psychologists, Clinical Psychologists, Research Lab Technicians, Research Phlebotomists and Clinical Research Fellow |
| Does this take place in participants' homes or at a central location? |
Central: Charing Cross Hospital, Hammersmith, London |
| Do participants take part individually or are families/partners involved? |
Individually |
| Dementia cases ascertained as part of study: |
No |
| Diagnosis based on review of existing clinical data |
No |
| Was diagnosis/primary outcomes made blind to exposure variables? |
No |
| How many times followed up? |
Every 6 months until December 2016 |
| Study start date |
11/19/2013 12:00:00 AM |
| Is study ongoing? |
No |
| Is study still recruiting? |
No |
| Inclusion criteria |
"1) Participants aged from 60 to 85 years inclusive
2) Willing and able to give written informed consent
3) Criterion modified per Amendment 6
3.1) Criterion modified per Amendment 7
3.2) Criterion modified per Amendment 9
3.3) Meets the definition of one of the following groups:
• High risk: The high risk group is operationally defined as participants whose age and education-adjusted baseline cognitive performance is 0.6 to 1.5 standard deviation (SD) (inclusive) below normal on the RBANS Immediate and/or Delayed
Memory Index, and 0.6 to 1.5 SD (inclusive) below normal on at least one other nonmemory RBANS cognitive domain.
• Medium risk (amnestic): The medium risk amnestic group is operationally defined as participants whose age- and education-adjusted baseline cognitive performance is 0.6 to 1.5 SD (inclusive) below normal only on the RBANS Immediate and/or
Delayed Memory Index, and all other RBANS nonmemory domains within normal limits operationally defined as better than 0.6 SD below normal.
• Medium risk (nonamnestic): The medium risk nonamnestic group is operationally defined as participants whose age- and education-adjusted baseline cognitive performance is better than 0.6 SD below normal on the RBANS Immediate and
Delayed Memory Index, and one or more other RBANS domains are 0.6 to 1.5 SD (inclusive) below normal.
• Low risk: The low risk group is operationally defined as participants whose ageand education-adjusted baseline cognitive performance on the RBANS is within normal limits, as defined for this study as all RBANS domains better than 0.6 SD below normal.
• Participants for whom an age- and education-adjusted baseline RBANS domain index score is more than 1.5 SD below normal will be adjudicated for inclusion.
4) Be willing and able to adhere to the prohibitions and restrictions specified in this protocol
5) Fluent in English
" |
| Exclusion criteria |
"1) Criterion modified per Amendment 6
1.1) Criterion modified per Amendment 7
1.2) Concurrent participation in an interventional trial. Enrollment in noninterventional trials is permitted only if the safety of the participant and integrity of the CHARIOT-PRO study data are not compromised by any of the following:
• High participant burden through enrollment in multiple studies
• Blood draw requirements beyond the permissible amount according to local recommended blood donation limits
• Cumulative exposure to radiation that exceeds local recommended exposure limits
• Exposure to the neuropsychological measures in CHARIOT-PRO that may impact participant performance (eg, learning effects)
2) Dementia or MCI diagnosis
3) Past or current use of memantine or cholinesterase inhibitors
4) Criterion modified per Amendment 6
4.1) Diagnosis of other neurologic disease or conditions known to cause or be associated with dementia, such as Parkinson’s disease
5) A history of traumatic brain injury with residual neurological deficit
6) Criterion modified per Amendment 7
6.1) History of stroke or diagnosis of transient ischemic attack (TIA)
7) History of seizures, excluding febrile seizures in childhood
8) Criterion modified per Amendment 6
8.1) Current diagnosis of significant psychiatric illness, as per the Diagnostic &
Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IVTR) (including but not limited to major depressive disorders and anxiety disorders) and is currently in an acute phase/episode, or the participant has a current diagnosis or history of schizophrenia or bipolar disorder
9) Reversible causes of dementia such as B12 deficiency, metabolic problems and/or nutritional deficiencies (eg, folic acid)
10) History of hydrocephalus at any time |