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

NCT05163067 | Not Yet Recruiting DMC

• 1 other identifier: ICND20210820
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; cognitive training; prevention; aerobic exercise; genetic susceptibility; neural plasticity

Outcome Measures

Primary Outcomes (10)

• Change in cognitive function over time as assessed by the Montreal Cognitive Assessment (MoCA)

  MoCA will be performed to evaluate the cognition of participants at the enrollment and year 1, year 3, year 5, year 7. The score ranges from 0 to 30, with higher values indicating better cognition.

  baseline time, year 1, year 3, year 5, year 7

• Change in cognitive function over time as assessed by Mini Mental State Examination (MMSE)

  MMSE will be performed to evaluate the cognition of participants at the enrollment and year 1, year 3, year 5, year 7. The score ranges from 0 to 30, with higher values indicating better cognition.

  baseline time, year 1, year 3, year 5, year 7

• Change in cognitive function over time as assessed by Clinical Dementia Rating (CDR)

  CDR will be performed to evaluate the cognition of participants at the enrollment and year 1, year 3, year 5, year 7. The score ranges from 0 to 18, with higher values indicating worse cognition.

  baseline time, year 1, year 3, year 5, year 7

• Change in cognitive function over time as assessed by Verbal Fluency Test

  Verbal Fluency Test will be performed to evaluate the semantic memory function of participants at the enrollment and year 1, year 3, year 5, year 7. Participants are asked to produce as many animals as possible within 1 minute. The score is the number of animals, with higher scores indicating better cognition.

  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

  Digit Span Tests will be performed to evaluate the working memory of participants at the enrollment and year 1, year 3, year 5, year 7. The total scores are twelve for each test, with higher values indicating better cognition.

  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)

  TMT-A and TMT-B will be performed to evaluate the executive function of participants at the enrollment and year 1, year 3, year 5, year 7. Scoring is based on time taken to complete the test (e.g., 35 seconds yielding a score of 35), with lower scores indicating better cognition.

  baseline time, year 1, year 3, year 5, year 7

• Change in cognitive function over time as assessed by Boston Naming Test (BNT)

  BNT will be performed to evaluate the language function of participants at the enrollment and year 1, year 3, year 5, year 7. The score ranges from 0 to 30, with higher values indicating better cognition.

  baseline time, year 1, year 3, year 5, year 7

• Change in cognitive function over time as assessed by California Verbal Learning Test (CVLT)

  CVLT will be performed to evaluate the memory function of participants at the enrollment and year 1, year 3, year 5, year 7. Participants are asked to finish immediate recall, delayed recall, and delayed recognition tasks in the test, with higher scores indicating better cognition.

  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)

  ROCF will be performed to evaluate the visuospatial function and other cognition domains of participants at the enrollment and year 1, year 3, year 5, year 7. Participants are asked to produce a complicated line drawing, with higher scores indicating better cognition.

  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

  The area under curve is used to show the ability of the SNP model (rs3777215, rs234434, rs71352238 and rs4420638) to diagnose AD. The value of area under curve is higher, then the ability of the SNP model to diagnose AD is stronger.

  up to 7 years

Secondary Outcomes (5)

• Change in whole brain volume as accessed by brain MRI

  baseline time, year 1, year 3, year 5, year 7

• Change in daily function over time as assessed by Activities of daily living (ADL)

  baseline time, year 1, year 3, year 5, year 7

• Change in anxiety over time as assessed by Hamilton Anxiety Rating Scale (HAMA)

  baseline time, year 1, year 3, year 5, year 7

• Change in depression over time as assessed by Hamilton Depression Scale (HAMD)

  baseline time, year 1, year 3, year 5, year 7

• Change in neuropsychiatric symptoms over time as assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q)

  baseline time, year 1, year 3, year 5, year 7

Study Arms (2)

Combined aerobic exercise and cognitive training program

EXPERIMENTAL

Behavioral: Combined aerobic exercise and cognitive training program

Standard health counseling at baseline

NO INTERVENTION

Interventions

Combined aerobic exercise and cognitive training program BEHAVIORAL

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.

Combined aerobic exercise and cognitive training program

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

Related Publications (5)

• 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-wide association study. Brain. 2021 Apr 12;144(3):924-937. doi: 10.1093/brain/awaa364.

  PMID: 33188687 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Longfei Jia, MD,PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Longfei Jia, MD,PhD

CONTACT

+86 10 83199456; longfei@mail.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 20, 2021
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: July 21, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)