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Primary Prevention of Alzheimer's disease: Examining the effects of cognitive behavioral therapy on cognitive function and amyloid-beta in older adults with symptoms of insomnia

Award Number: R01AG058530
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease. However, despite the strong links between sleep disruptions, cognitive decline, and Alzheimer's disease, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent Alzheimer's disease. Approximately 15% of Alzheimer's disease may be attributed to sleep disruptions. Individuals with insomnia are more likely to be diagnosed with Alzheimer's disease and demonstrate decline in cognitive function at long-term follow-up. An intervention aimed at improving insomnia is a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of Alzheimer's disease. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for insomnia, but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aß accumulation has never been examined. Therefore, the long-term goal of this research agenda is to understand how addressing sleep disturbances may delay the onset of AD. The objective of the proposed study is to compare the efficacy of CBT-I on improving cognitive function older adults with symptoms of insomnia. The aims of the study are to examine the efficacy of CBT-I on improving cognitive function in older adults with symptoms of insomnia (Aim 1), determine the association between change in sleep measures and change in cognitive function (Aim 2), and examine the efficacy of CBT-I on reducing the rate of Aß deposition in older adults with symptoms of insomnia (exploratory aim). This study is directly in line with PAR-18-175 to assess “sleep enhancement” as a “non-pharmacological intervention” to address “age-related cognitive decline” in older adults who are “pre-symptomatic.” Two hundred (n=200) cognitively normal (CDR = 0) individuals age 60-85 with symptoms of insomnia will be recruited. Participants will be randomly assigned to a 6-week one-on-one cognitive behavioral therapy for insomnia (CBT-I) intervention or to an active control condition. Participants will undergo a sophisticated battery of cognitive tests and polysomnography to assess sleep quality and sleep characteristics at baseline and reassessment immediately following the intervention and at a 1 year. A subgroup of individuals (n=50) will undergo Florbetapir PET imaging to examine the efficacy of CBT-I on reducing the rate of Aß deposition at baseline and at the 1 year reassessment. Effective interventions that could delay the onset of Alzheimer's disease are critically needed. This research is significant because approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders. This proposed study is innovative because no prior studies have targeted sleep disturbances as a possible opportunity to impact the development of Alzheimer's disease.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $699,698 )
2023	2023	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Aging Research	000	5	7/13/2023	NON-COMPETING CONTINUATION	$699,698


Issue Date FY: 2022 ( Subtotal = $721,234 )
2022	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	000	4	8/24/2022	NON-COMPETING CONTINUATION	$721,234


Issue Date FY: 2021 ( Subtotal = $736,351 )
2021	2021	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	001	3	8/12/2021	NON-COMPETING CONTINUATION	$736,351
2021	2020	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	000	2	11/5/2020	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2020 ( Subtotal = $751,228 )
2020	2020	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	000	2	12/26/2019	NON-COMPETING CONTINUATION	$676,105
2020	2020	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	001	2	1/23/2020	NON-COMPETING CONTINUATION	$75,123


Issue Date FY: 2019 ( Subtotal = $763,979 )
2019	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	000	1	1/15/2019	NEW	$763,979
2019	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	001	1	2/26/2019	NEW	$0
2019	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Aging Research	002	1	3/4/2019	NEW	$0


Grand Total All Awards = $3,672,490

Sum of Action Amount is $3,672,490;

Grand Total = $3,672,490

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Primary Prevention of Alzheimer's disease: Examining the effects of cognitive behavioral therapy on cognitive function and amyloid-beta in older adults with symptoms of insomnia

Award Number: R01AG058530

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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