Research
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 Institute 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.
Active Research projects
The purpose of the current study is to assess the effectiveness of Transcranial Magnetic Stimulation (TMS) as an adjunct to standard-of-care speech language therapy (SLT) on delaying the progression of speech problems in patients with Primary Progressive Aphasia (PPA).
Patients with PPA who participate in the study are examined by expert clinicians at the beginning of the study, prior to pursuing the combined SLT-TMS therapeutic protocol. Participants are assessed for language abilities at the beginning of the study, as well as throughout regular intervals until the end of the study.
At the end of the protocol participants will be given concrete feedback on whether and to what extent they benefited from the interventions, while also help in identifying novel treatments that can potentially prove helpful to more people with PPA.
Any patient with a PPA that is participating in standard-of-care SLT can participate in the study.
This study has been supported in part by discretionary funds of the Sleep & Memory Center at the NIA.
For more information e-mail at: info@nioa.gr or call at 210-72-17-457.
The purpose of the current study is to study the association of CGRP-related pathways with the development and progression of Clinicopathologically-established Parkinson’s Disease (CPPD). We partially understand PD pathophysiology and there are currently no available effective treatments. CGRP has anti-inflammatory properties and modulating CGRP-related pathways may lead to novel PD disease-modifying therapies.
We will, examine through a novel protocol the unexplored associations of CGRP and its potential related pathways with known CPPD biomarkers in blood and skin biopsies. Assessments will be exploited from the ongoing MES-CoBraD protocol, and we will pursue a longitudinal study on thoroughly examined (history, physical exam, cognitive, neurophysiological testing, biosamples, imaging) people with CPPD and matched healthy individuals. In sum, we will investigate the associations of CGRP-related biomarkers, towards improving diagnostic and prognostic precision, discovering disease-modifying interventions and identification of personalized therapies.
The study has been funded by the Alzheimer's Association (Grant Agreement ID: AACSF-22-971298) and implemented between October 1st 2022 and September 30th 2025.
https://www.alz.org/research/for_researchers/grants/funded-studies-details?FundedStudyID=2822
The purpose of the current study is to examine the association between tablet-based and wearable digital biomarkers that assess motor and cognitive function with biofluid markers of degeneration in adults with presymptomatic or early symptomatic Alzheimer’s disease. Through this study, we will be able to better understand AD pathophysiology for identifying new therapeutic targets, as well as whether digital biomarkers can be used for earlier and faster diagnosis.
During the study, participants complete a clinical and cognitive examination with a trained Neurologist, participate in tablet-based digital biomarker testing, and provide blood as well as cerebrospinal fluid through a lumbar puncture. Additionally, they obtain a wearable wrist device that measures activity levels and predicts sleep-wake rhythms, which the participants will keep upon the completion of the study. Assessments are performed annually for five years.
Inclusion criteria are: (1) age above 50 years old, (2) with subjective cognitive concerns or mild cognitive impairment or mild dementia, (3) caregiver availability for visits and provision of history, (4) ability to understand study requirements and provide informed consent, and (5) access to a smartphone or tablet at home to synchronize with wearable device.
The study is funded by Altoida Inc. and Eisai Inc. and implemented between July 2023 and July 2028.
Completed 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.
This study has been funded by the Alzheimer’s Association and the Global Brain Health Institute (Grant Agreement ID: GBHI_ALZ-18-543785) and implemented between April 1st 2019 and June 30th 2023.
https://www.alz.org/research/for_researchers/grants/funded-studies-details?FundedStudyID=932
For more information e-mail at: info@nioa.gr or call at 210-72-17-457.
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.
This study has been funded by the Alzheimer’s Association and the Global Brain Health Institute (Grant Agreement ID: GBHI ALZ UK-19-588605) and implemented between January 1st 2019 and June 30th 2023.
https://www.alz.org/research/for_researchers/grants/funded-studies-details?FundedStudyID=2228
For more information e-mail at: info@nioa.gr or call at 210-72-17-457.
The purpose of the MES-CoBraD study is to collect and analyze real-world data (RWD) from daily practice in order to improve early diagnosis, prognosis, and identify optimal therapies for patients with Complex Brain Disorders (CoBraD), such as neurocognitive, epilepsy, and sleep disorders.
Through the MES-CoBraD, new multidisciplinary clinical protocols of precision medicine are implemented, and collected RWD are analyzed with the use of Advanced Analytics and Artificial Intelligence (AI), towards improving the quality of life of patients, their caregivers, and society at large.
The study has been funded by the European Union (Horizon2020 Research & Innovation Action Grant Agreement ID: 965422) and implemented between April 1st 2021 and March 31st 2024.
https://clinicaltrials.gov/ct2/show/results/NCT05171725?view=results
For more information e-mail at: info@nioa.gr or call at 210-72-17-457.