Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease (Scope)
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|ClinicalTrials.gov Identifier: NCT01841905|
Recruitment Status : Unknown
Verified January 2016 by Rhode Island Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 29, 2013
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment|
|Alzheimer's Disease||Other: Observational Study|
We will take pictures of subjects' brains using PET imaging, in healthy older adults (ages 55 to 80 years) who have both a family history of AD, and who have concerns about changes in their memory (but no clinical symptoms of AD), to see how much of a protein - that is related to AD -is in their brains. When all subjects come to the hospital for PET imaging, we will review the entire study plan with them, the risks and benefits of participation, and we will obtain written informed consent at that time. Our goal is to compare performance on our new stress test to these PET imaging results. Once the PET imaging is done, we will have each subject come to our clinical research unit for a day-long baseline visit. In the morning we will give the tests of memory and thinking, and then we will administer the injection of scopolamine at a very low dose. We will then continue to examine the subjects, and to give the memory and thinking tests at 1, 3, 5, 7, and 8 hours post-dosing. Once they have fully-recovered from all effects of the medication, they will be allowed to go home that day. We will then see all subjects again, for much shorter visits to complete the cognitive tests, at both 9 and 18 months after their initial study visit. We will follow all subjects for 18 months to see which of them show very mild but measurable changes on the memory and thinking tests, as we predict that these will be the same persons who also had stronger results on our stress test at the first study visit.
At all three study visits to our clinical research unit, we will obtain measurements using an imaging device that uses infrared and blue light to take picture of the eye and retina. Our secondary goal in this study to search for evidence of the same protein, in the retina, that builds up and is seen with PET imaging of the brain in persons who are at high risk for AD. Finally, we are also collecting a small sample of saliva, at the first visit to our unit, in order to see which subjects have a genetic risk for the disease, as this genetic risk may affect how we interpret the results of our new "cognitive stress test".
In this study, a small dose of an already approved medication (used to treat seasickness) will be used to temporarily, and safely, mimic signs of very early disease during just the first day of testing. This is a methodological study to determine if tests that measure how you think can predict the risk of dementia as we age.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Pre-Symptomatic Alzheimers' Disease
Other: Observational Study
- Groton Maze Learning Test [ Time Frame: 18 Months ]Total number of correct moves over 5 trials on the Groton Maze Learning Test at 3 hours
- Groton Maze Learning Test [ Time Frame: 18 Months ]Mean number of correct moves per second on the Groton Maze Learning Test at 3 hours
- CogState One-Back Learning (OBK) Task [ Time Frame: 18 Months ]Overall performance across study visits.
- 12-Item International Shopping List Test - Immediate and Delayed Recall (CogState) [ Time Frame: 18 Months ]Overall performance across study visits.
- Rentz Face-Name Association Test [ Time Frame: 18 Months ]Overall performance across study visits.
- Stark Pattern Separation Test [ Time Frame: 18 Months ]Overall performance across study visits.
- Minnesota Cognitive Acuity Scale (MCAS) [ Time Frame: Pre-baseline ]Screening acuity.
- Saliva Sample for DNA Analyses (ApoE and BDNF genotyping) [ Time Frame: Baseline ]Mutation status.
- Non-invasive imaging of macula, retinal function and visual fields [ Time Frame: 18 Months ]Change over time.
- CogState Once-Card learning (OCL) Task [ Time Frame: 18 Months ]Overall performance across study visits.
- Amyloid and Alzheimer's Psycho-educational Session [ Time Frame: 9 and 18 month study visits ]An informational exercise to provide further information about amyloid PET imaging and to determine the impact of this disclosure of study participants.
- Tokyo Subway Navigation [ Time Frame: 9 month follow-up visit ]A functional activity of daily living where study participants are given pre-determined destinations / conditions and asked to map the route. Main outcome measure for this assessment is time taken to solve the problem.
- MAC-Q [ Time Frame: Pre-screen, Baseline, 9 & 18 month follow-up ]A six-item scale measuring age-related memory decline. An overall index of cognitive decline is calculated by summing scores for all six items with double weighting for item #6. Higher scores indicate greater decline in memory.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841905
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Peter J. Snyder, Ph.D.||Sr. Vice President & Chief Research Officer, Lifespan|