Cognitive impairment in the elderly
Conditions
Interventions
Study 1: mild cognitive impairment(MCI)group:Nil
Study 1:early-stage Alzheimer's disease group:Nil
Study 2:control group of healthy young people:sham repetitive transcranial magnetic stimulation
Study 2:treatment group of healthy young people:repetitive transcranial magnetic stimulation
Study 3:control group of healthy elderly:sham repetitive transcranial magnetic stimulation
Study 3: treatment group of healthy elderly group:repetitive transcranial magnetic stimulation
Study 4: control group of subjective cognitive decline(SCD) group:sham repetitive transcranial magnetic stimulation
Study 1: healthy young group:Nil
Study 1: healthy elderly group:Nil
Study 1: subjective cognitive decline(SCD)group:Nil
Study 4: treatment group of subjective cognitive decline(SCD) group:repetitive transcranial magnetic stimulation
Study 5:control group of mild cognitive impairment(MCI) group:sham repetitve transcranial magnetic stimulation
Study 5:treatment group of mild cognitive impairment(MCI) group:repetitive transcranial magnetic stimulation
Study 6:control group of early-stage Alzheimer's disease:sham repetitive transcranial magnetic stimulation
Study 6:treatment group of early-stage Alzheimer‘s disease:repetitive transcranial magnetic stimulation
Sponsors
The Affiliated JiangSu Shengze Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Healthy young subjects: (1) Aged 20 to 30 years; (2) Right-handed; (3) No chief complaint of cognitive impairment; (4) Mini-Mental State Examination (MMSE) scored > 24 points and 26 points; (6) Clinical Dementia Rating (CDR) score 0; (7) The subject signs the informed consent. 2.Healthy elderly subjects: (1) Aged 55 to 80 years; (2) Right-handed; (3) No chief complaint of cognitive impairment; (4) Mini-Mental State Examination (MMSE) scored >24 points and 26 points; (6) Clinical Dementia Rating (CDR) score 0; (7) The subject signs the informed consent. 3.SCD subjects: (1) Aged 55 to 80 years; (2) Right-handed; (3) Meet the 2018 NIA-AA Neuropsychological Diagnostic Criteria for SCD: 1) Did not meet the neuropsychological diagnosis of MCI; 2) Self-experienced persistent memory decline for at least 6 months, compared with a previous normal state, which is not associated with acute event; 3) Self-report concerns of memory decline; (4) The subject signs the informed consent. 4.MCI subjects: (1) Aged 55 to 80 years; (2) Right-handed; (3) Meet the 2018 NIA-AA MCI Neuropsychology Standards, and meet one of the following conditions: 1) The scores of two neuropsychological tests in at least one cognitive domain were lower than 1.0SD; 2) In all three cognitive domains, one neuropsychological test score was lower than 1.0SD; 3) The score of Functional Activities Questionnaire (FAQ) was =9 points. Note: The three cognitive domains assessed in MCI include: Memory function; Executive function; Language functions. (4) The subject signs the informed consent. 5.AD early subjects: (1) Aged 55 to 80 years(inclusive); (2) Right-handed; (3) AD diagnosis was performed according to the 2011 edition of NIA-AA standard and the 2007 revised edition of NICD-ADRDA standard: 1) The diagnostic criteria of dementia in accordance with the American Psychiatric Association's "Diagnostic and Statistical Manual of Mental Disorders," the fourth edition of the revised edition: the patient's symptoms affect daily life and work; The cognitive level and function decreased compared with those before onset. Impairment of at least two of the following cognitive domains and psychiatric symptoms (the ability to learn and remember new information; Executive function; Language function; Visual spatial ability; Existence of personality, behavioral abnormalities and other psychiatric symptoms); Exclude delirium and other psychiatric disorders (such as depression); 2) the onset of latent attacks, symptoms in a few months to years gradually appear; 3) The primary and most prominent cognitive impairment was episodic memory impairment, which included at least one other cognitive impairment; 4) MRI showed decreased volume of hippocampus, entorhinal cortex, and amygdala (compared with the same age) or confirmed autosomal dominant inheritance of AD in immediate family members; 5) exclude other neurological diseases or complications of non-neurological diseases or use drugs that affect cognition; 6) AD should not be diagnosed when there is evidence of cerebrovascular dementia, Lewy body dementia, frontotemporal dementia and other diseases; 7)MMSE score >= 12 points and < 24 points; (4) Subjects' family members signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Meet the diagnostic criteria for vascular dementia developed by the National Institute of Neurology and Stroke in the United States and the International Association for Research in Neuroscience in Switzerland (NINDS-AIREN); 2. The modified Hachinski Ischemia Scale scored > 4 points; 3. Can not cooperate with the cognitive function test (including blindness, deafness, severe language impairment, etc.); 4. Previous 6 months of drug or alcohol dependence; 5. Participating in other clinical studies; 6. Irritable; 7. Complicated with serious cardiovascular disease, cerebrovascular disease, liver disease, kidney disease and mental disease; 8. Failure to cooperate with FMIR test; 9. Have a history of epilepsy, have a history of idiopathic epilepsy among first-degree relatives and use of epileptic drugs; 10. Skull defect at the site of TMS stimulation; 11. Patients treated with psychoactive drugs including anticholinesterase inhibitors or NMDA antagonists at least 2 weeks prior to cognitive assessment (this does not apply to patients with early AD); 12. Implants such as cardiac pacemakers, artificial metal heart valves, insulin pumps, drug therapy pumps, aneurysm clips (except non-paramagnetic titanium alloy); 13. Claustrophobic; 14. Treatment with central nervous system medications that could affect cortical excitability within 1 month prior to assessments; 15. Geriatric depression scale scores >= 6.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dorsolateral prefrontal cortex plasticity(Study 1);The episodic memory test(Study2);short-latency afferent inhibition(Study1);motor cortex plasticity(Study1);working memory(n-back)(Study3,4,5);Alzheimer’s disease assessment scale,ADAS-cog(Study 6); | — |
Secondary
| Measure | Time frame |
|---|---|
| functional magnetic resonance imaging,fMRI (Study1,3,4,5,6);blood test(Study1,3,4,5,6);dorsolateral prefrontal cortex plasticity(Study2,3,4,5,6);Event-related potentials,ERPs;the MOS item short from health survey, SF-36(Study1,3,4,5,6);The geriatric depression scale,GDS(Study1,3,4,5,6);mini-mental state examination, MMSE(Study1,3,4,5,6);Montreal cognitive assessment,MoCA(Study1,3,4,5,6);Alzheimer’s disease assessment scale-cognitive section,ADAS-cog(Study 1:AD group);working memory(n-back)(Study1);inhibition control(Go/No-Go)(Study1,2,3,4,5,6);wechsler digital memory span test(Study1,3,4,5,6);wechsler logic memory test(Study1,3,4,5,6);Auditory Verbal Learning Test-Huashan version (AVLT-H)(Study1,3,4,5,6);Boston Naming Test China version(BNT-C)(Study1,3,4,5,6);Animal Fluency test(Study1,3,4,5,6);Shape Trail Test-A China version(STT-A-C)(Study1,3,4,5,6);Shape Trail Test-B China version(STT-B-C)(Study1,3,4,5,6);Digit Symbol Substitution Test,DSST(Study1,3,4,5,6);Pittsburgh sleep quality index(PSQI)(study4,5); | — |
Countries
China
Contacts
Public ContactShen Ying
The First Affiliated Hospital of Nanjing Medical University/Jiangsu Provincial People's Hospital
Outcome results
None listed