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Research is one of the core activities at the NIA, in line with its duty to be a force of positive change for brain health by promoting novel and innovative diagnostic and therapeutic protocols. Our projects aim to develop novel protocols that provide more accurate and earlier diagnosis for complex neurological disorders, explore novel therapeutic avenues that improve patients’ and caregivers’ quality of life through clinical trials, and advance our understanding of brain function. Our projects are conducted according to medical research ethical principles through independent research funding to our center and through collaborative multinational projects.

Medical Research Ethics

Effective and quality research is best achieved by following ethical principles of patient autonomy, justice, beneficence and non-maleficence, while respecting personal information through data privacy and security. For this reason, all research projects pursued at the NIA are first approved by our Institutional Review Board. In the end, participation in research starts and ends according to a patient’s desires and priorities.​

Research conducted at the NIA​

Clinical Research pursued at the NIA can be categorized into observational clinical research and clinical trials. In observational research people are assessed on biological or behavioral variables that affect quality of life, such as cognition, behavior, movement, blood or CSF biomarkers, and physiology in general, and associations are drawn between these variables and clinical and social outcomes that can inform future medical decision making. Clinical trials are studies where people receive a medical intervention, pharmacological or non-pharmacological (e.g., psychotherapy, lifestyle modifications, medical device intervention), and the intervention’s effects and side-effects are examined with relation to relevant variables that have been previously considered important during observational trials.​

Research projects

The purpose of the study is to answer whether Sleep Health Education (SHE) or Cognitive Behavioral Therapy for Insomnia (CBTi) can be effective in improving insomnia symptoms for people with MCI or mild dementia and secondarily delay cognitive decline and improve mood. This project will pave the way for the development of other scalable low-cost interventions that are tailored to patients with cognitive decline and their families, and has the potential to influence policy and clinical practice around the treatment of sleep disorders in neurocognitive disorders.

SHE is implemented regularly in clinical practice, where clinicians educate patients on how to best structure daily activities around healthy sleep habits. It is low cost and can be easily comprehended by the majority of people. CBTi is an established treatment for insomnia in cognitively healthy older adults that relies on multiple components (e.g., reconstructing maladaptive beliefs about sleep, behavioral modification) that are cognitively taxing to a person and require several encounters. Controlled trials are lacking in establishing whether either treatment intervention can be effective in people with neurocognitive disorders.

People with mild cognitive impairment or mild dementia with insomnia symptoms who participate in the project provide historical information on sleep and cognitive symptoms, as well as medications and past medical history, and undergo detailed neuropsychological testing, actigraphy, and polysomnography prior to being randomized in one of two treatment groups (SHE vs. CBTi). After participating in SHE or CBTi interventions, they are re-evaluated at three months through questionnaires and neuropsychological testing, and then at a year’s time through questionnaires, neuropsychological testing, actigraphy and polysomnography. If the study reveals that either of the two treatments were helpful to people, the people who did not receive the specific treatment will be given the option to receive it upon completion of the study.

Funding organizationAlzheimer’s Association and Global Brain Health Institute

The purpose of the study is to answer whether Sleep Health Education (SHE) or Cognitive Behavioral Therapy for Insomnia (CBTi-dt) can be effective in improving insomnia symptoms for people with MCI or mild dementia and secondarily delay cognitive decline and improve mood. This project will pave the way for the development of other scalable low-cost interventions that are tailored to patients with cognitive decline and their families, and has the potential to influence policy and clinical practice around the treatment of sleep disorders in neurocognitive disorders.

SHE is implemented regularly in clinical practice, where clinicians educate patients on how to best structure daily activities around healthy sleep habits. It is low cost and can be easily comprehended by the majority of people. CBTi-dt is an established treatment for insomnia in cognitively healthy older adults that relies on multiple components (e.g., reconstructing maladaptive beliefs about sleep, behavioral modification) that are cognitively taxing to a person and require several encounters. Controlled trials are lacking in establishing whether either treatment intervention can be effective in people with neurocognitive disorders.

People with mild cognitive impairment or mild dementia with insomnia symptoms who participate in the project provide historical information on sleep and cognitive symptoms, as well as medications and past medical history, and undergo detailed neuropsychological testing, actigraphy, and polysomnography prior to being randomized in one of two treatment groups (SHE vs. CBTi-dt). After participating in SHE or CBTi-dt interventions, they are re-evaluated at three months through questionnaires and neuropsychological testing, and then at a year’s time through questionnaires, neuropsychological testing, actigraphy and polysomnography. If the study reveals that either of the two treatments were helpful to people, the people who did not receive the specific treatment will be given the option to receive it upon completion of the study.

Funding organization: Alzheimer’s Association and Global Brain Health Institute

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