Combined Aerobic Exercise and Cognitive Training in Seniors With Genetic Susceptibility for Alzheimer's Disease

Официальное название

Combined Aerobic Exercise and Cognitive Training for Alzheimer's Disease Prevention in Seniors With Genetic Susceptibility Estimated by Polygenic Risk Models: Cognition and Neural Plasticity Effects

Обзор

The study aims to investigate the effect of a long-term combined aerobic exercise and cognitive training program on cognitive function, daily function, psychosocial status, and neural plasticity in seniors with genetic susceptibility for Alzheimer's Disease.

Подробное описание

Alzheimer's disease (AD) is the most common type of dementia and the leading cause of disability in people older than 65 years worldwide. However, there is no effective disease-modifying therapy currently. Therefore, improvement of cognitive function in people at risk and, potentially, prevention of cognitive decline has been gaining attraction.

Our previous research reported a model of a combination single nucleotide polymorphism (SNP) (rs3777215, rs234434, rs71352238, and rs4420638) can predict AD onset with high performance, which is useful to identify people at risk for AD and thus allows for timely treatment and prevention.

Both aerobic exercise and cognitive training have been demonstrated beneficial effects on cognition in subjects with AD and healthy populations. Moreover, the synergistic effects of the combination have been proven recently. However, the effect of combined aerobic exercise and cognitive training on seniors with genetic susceptibility for AD remains to be elucidated. Herein, this study aims to

1. assess the effects of long-term combined aerobic exercise and cognitive training on cognitive function, daily function, psychosocial status, and neural plasticity in seniors with single nucleotide polymorphism of rs3777215, rs234434, rs71352238, and rs4420638. 2. confirm the predictive value of the SNP model for AD in a longitudinal setting.

Вмешательства

• Поведенческое Combined aerobic exercise and cognitive training program
  Participants will take part in a combined aerobic exercise and cognitive training program. The program will include moderate cycling exercise and cognitive game resolving at the same time. The tasks will be instructed and supervised by a fitness expert and a trained clinical neuropsychologist.

Первичные конечные точки

• Change in cognitive function over time as assessed by the Montreal Cognitive Assessment (MoCA) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by Mini Mental State Examination (MMSE) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by Clinical Dementia Rating (CDR) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by Verbal Fluency Test [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by Digit Span Test-Forward and Backward [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by Trail-Making Test Parts A and B (TMT-A and TMT-B) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by Boston Naming Test (BNT) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by California Verbal Learning Test (CVLT) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in cognitive function over time as assessed by the Rey-Osterrieth Complex Figure Test (ROCF) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• The area under curve of the SNP model (rs3777215, rs234434, rs71352238 and rs4420638) for the accurate diagnosis of AD [Срок оценки: up to 7 years]

Вторичные конечные точки (5)

• Change in whole brain volume as accessed by brain MRI [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in daily function over time as assessed by Activities of daily living (ADL) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in anxiety over time as assessed by Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in depression over time as assessed by Hamilton Depression Scale (HAMD) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]
• Change in neuropsychiatric symptoms over time as assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q) [Срок оценки: baseline time, year 1, year 3, year 5, year 7]

Критерии участия

Критерии включения

• Mandarin-speaking subjects.
• Not clinically demented.
• Meeting the cutoff values of MMSE and CDR.
• With positive variation of rs3777215, rs234434, rs71352238, and rs4420638.

Критерии исключения

• Had major neurologic diagnosis (e.g., Parkinson's disease, stroke, encephalitis, and epilepsy) or other condition that might impair cognition or confound assessments.
• Had a history of psychotic episodes or had major depression (Hamilton Depression Rating Scale score > 24 points).
• Had severe systemic diseases, such as tumors, cardiovascular or orthopedic disorder that can affect the ability to perform the proposed intervention tasks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Xuanwu Hospital — Пекин

Публикации

• Jia L, Li F, Wei C, Zhu M, Qu Q, Qin W, Tang Y, Shen L, Wang Y, Shen L, Li H, Peng D, Tan L, Luo B, Guo Q, Tang M, Du Y, Zhang J, Zhang J, Lyu J, Li Y, Zhou A, Wang F, Chu C, Song H, Wu L, Zuo X, Han Y, Liang J, Wang Q, Jin H, Wang W, Lu Y, Li F, Zhou Y, Zhang W, Liao Z, Qiu Q, Li Y, Kong C, Li Y, Jiao H, Lu J, Jia J. Prediction of Alzheimer's disease using multi-variants from a Chinese genome-wid PMID 33188687
• Jia L, Quan M, Fu Y, Zhao T, Li Y, Wei C, Tang Y, Qin Q, Wang F, Qiao Y, Shi S, Wang YJ, Du Y, Zhang J, Zhang J, Luo B, Qu Q, Zhou C, Gauthier S, Jia J; Group for the Project of Dementia Situation in China. Dementia in China: epidemiology, clinical management, and research advances. Lancet Neurol. 2020 Jan;19(1):81-92. doi: 10.1016/S1474-4422(19)30290-X. Epub 2019 Sep 4. PMID 31494009
• Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14. PMID 27838936
• Lopez-Ortiz S, Valenzuela PL, Seisdedos MM, Morales JS, Vega T, Castillo-Garcia A, Nistico R, Mercuri NB, Lista S, Lucia A, Santos-Lozano A. Exercise interventions in Alzheimer's disease: A systematic review and meta-analysis of randomized controlled trials. Ageing Res Rev. 2021 Dec;72:101479. doi: 10.1016/j.arr.2021.101479. Epub 2021 Sep 30. PMID 34601135
• Ben Ayed I, Castor-Guyonvarch N, Amimour S, Naija S, Aouichaoui C, Ben Omor S, Tabka Z, El Massioui F. Acute Exercise and Cognitive Function in Alzheimer's Disease. J Alzheimers Dis. 2021;82(2):749-760. doi: 10.3233/JAD-201317. PMID 34092631

Идентификаторы

NCT: NCT05163067 · ICND20210820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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