The aim of this study is to improve how cognitive fluctuations are identified and measured in people with dementia with Lewy bodies (DLB) and Alzheimer’s disease (AD). Researchers hope to develop more reliable and objective ways to track changes in attention, thinking, and alertness using physiological and imaging biomarkers.

What is this study about?

This is a 3-year longitudinal cohort study involving people with probable dementia with Lewy bodies or probable Alzheimer’s disease dementia. The research focuses on “cognitive fluctuations,” which are changes in cognition, attention, and alertness that can vary from minutes to days and are especially common in DLB.

Researchers are studying whether tools such as brain wave recordings, sleep monitoring, wearable activity devices, and brain imaging can help provide more objective measures of cognitive fluctuations.

What is involved?

Participants will complete a baseline visit followed by annual study visits over a 3-year period. Study partners (someone over the age of 18 who has regular contact with the study participant and is knowledgeable about their cognitive status will accompany participants on visits and provide information about the participant’s symptoms and daily functioning.

Procedures may include:

• Cognitive and neuropsychological testing focused on attention and executive functioning
• Care partner questionnaires and fluctuation scales
• Wearable activity monitoring (actigraphy, similar to a step counter) – worn for 14 days after enrollment, again at 12 month follow up and the 24 month follow up
• Electroencephalography (EEG) during rest and sleep to measure brain activity – one at time of enrollment, 12 month follow up, and at 24 month follow up
• 3T MRI scans are obtained at time of enrollment, the 12 month follow up, and the 24 month follow up
• Forehead sleep monitor is worn for 3 nights after enrollment, again at 12 month follow up and the 24 month follow up
• Review of available biomarker information confirming DLB or AD diagnosis to determine eligibility

Researchers will use these measures to better understand the presence, frequency, and stability of cognitive fluctuations over time.

Who can participate?

A person may be able to participate if they:

• Are 50 to 90 years of age
• Have 8 years of education and English proficiency
• Probable dementia with Lewy bodies (DLB), or probable Alzheimer’s disease dementia (AD)
• Have a care partner who can participate in study visits

Study Site

Study Funder/Sponsor

This study is funded by the National Institute of Neurological Disorders and Stroke (NINDS)

For more information, please contact the individual listed above for the site that interests you.