- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03119051
Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment (SIMPLE)
Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200002
- Rekruttering
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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Ta kontakt med:
- Binyin Li, Dr
- Telefonnummer: 86-13681884221
- E-post: libinyin@126.com
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Ta kontakt med:
- Yiqi Lin, Dr
- Telefonnummer: 86-021-64454473
- E-post: linyiqi@126.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male or female, aged 50-85;
- MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups[1];
- 24≤Mini-Mental State Examination (MMSE) ≤28;
- The Hamilton Depression Scale/17-item (HAMD) score ≤10;
- Not on medication for dementia;
- MRI T2 weighted image (T2WI) scan: aged ≤70 , Fazeca scale for White Matter lesions rating level≤1; >70 years, white matter damage rating scale ≤2. The number of lacunar infarcts larger than 2 cm in diameter ≤2. No infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. The medial temporal lobe atrophy (MTA) score: Grade II or above.
- Accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like ADCS-ADL;
- Education level: primary school (grade 6) or above.
- Expected good compliance with the therapy and follow-up. Each patient gives a written informed consent, and the study has been approved by Ruijin Hospital's ethical committees.
Exclusion Criteria:
- Cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, Parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin B12 and hypothyroidism);
- Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);
- Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;
- Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;
- History of alcohol or drug abuse;
- Participation in other clinical trial less than 30 days before the screening of this study;
- Inability to complete the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: online cognitive training
Patients will receive 3-4 times of 20-30 minutes' training game every week
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A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills.
The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
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Ingen inngripen: no training
Patients will not undergo preoperative cognitive training.
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Eksperimentell: Cognitive training and physical exercise
Patients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training
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Online cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%. Physical Exercise Tai Chi Training:a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence of AD
Tidsramme: 12 months
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The 3-year incidence of AD in each group will be compared.
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The global cognitive function of MCI patients
Tidsramme: 6 months
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Alzheimer disease assessment scale (ADAS-Cog) will be used to assess the global cognitive performance of MCI patients
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6 months
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Memory
Tidsramme: 12 months
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Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
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12 months
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Attention
Tidsramme: 12 months
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Attention will be evaluated by Trial Making Test (TMT).
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12 months
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Executive functions
Tidsramme: 12 months
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Executive functions will be evaluated by the Stroop task.
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12 months
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Language
Tidsramme: 12 months
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Language will be assessed by Boston naming test (30-item version).
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12 months
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Visual spatial ability and visual memory
Tidsramme: 12 months
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Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).
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12 months
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Activities of daily living
Tidsramme: 6 months
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Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
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6 months
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Structural MRI
Tidsramme: 12 months
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Volume of hippocampus and other specific brain regions
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12 months
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Gut microbiota
Tidsramme: 12 months
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Number of genera and abundence of E.coli in feces and blood
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12 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Sheng-Di Chen, Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RuijinHSH
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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