Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment (CogMCI)
27 de agosto de 2013 atualizado por: Chul Soo Kim, Inha University Hospital
A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment
- There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group.
- There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.
Tipo de estudo
Intervencional
Inscrição (Real)
293
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ansan, Republica da Coréia
- Korea University Medical College
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Bucheon, Republica da Coréia, 420-767
- Soonchunhyang University Hospital
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Bucheon, Republica da Coréia
- Bucheon St. Mary's Hospital, The Catholic University of Korea
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Busan, Republica da Coréia
- Pusan National University Hospital
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Busan, Republica da Coréia, 602-715
- DongA University Hospital
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Daejun, Republica da Coréia, 302-799
- Daejun Eulji University Hopistal
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Goyang, Republica da Coréia
- NHIC Ilsan Hospital
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Goyang, Republica da Coréia, 412-270
- MyongJi Hospital
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Incheon, Republica da Coréia, 400-711
- Inha Univeristy Hospital
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Jeju, Republica da Coréia
- Jeju National University Hospital
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Pusan, Republica da Coréia
- Maryknoll Hospital
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Seongnam, Republica da Coréia
- bobath Memorial Hospital
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Seoul, Republica da Coréia
- Inje University Sanggye Paik Hospital
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Seoul, Republica da Coréia, 135-710
- Sungkyunkwan University, Samsung Seoul Hospital
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Seoul, Republica da Coréia, 431-060
- Asan Medical Center, Psychiatry
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Seoul, Republica da Coréia
- Konkuk University Medical Cener
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Suwon, Republica da Coréia
- Ajou University Hospital
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Yongin, Republica da Coréia
- Hyoja Geriatric Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- 50 to 85 years of age
- memory complaint corroborated by a participant and an informant
- delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
- Global CDR score is 0.5, Memory CDR score is 0.5 or 1.
- above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
- normal functional activities
- not diagnosed with dementia
- Modified Hachinski Ischemic Score (HIS): 0-4
- brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
- Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
- He/She can read and write
- written informed consent
Exclusion Criteria:
- any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
- any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
- any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
- any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
- any patients with any history of drug or alcohol addiction during the past 10 years
- any hearing or visual impairment that can disturb the efficient evaluation of the patient
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Group cognitive intervention
The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics.
Each session will last approximately 90 minutes.
The cognitive training programs will be offered in group sessions consisted of 5 participants.
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The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics.
Each session will last approximately 90 minutes.
The cognitive training programs will be offered in group sessions consisted of 5 participants.
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Comparador Ativo: Home-based cognitive intervention
The participants will do their homework for 30 minutes every business days for 12 weeks.
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The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
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Sem intervenção: Wait list Control
They will participate in cognitive intervention after ending this study.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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story recall test
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Digit span forward and backward
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Word fluency test
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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color-word stroop test
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Digit symbol test
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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prospective memory test
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Mini-Mental State Examination
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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CDR-SB
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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K-AD8
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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PRMQ
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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MMQ-Strategy
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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QOL-AD
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Geriatric Depression Scale-short form
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Bayer ADL
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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CGA-NPI
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Subjective cognitive assessment
Prazo: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Seong H Choi, MD, PhD, Inha University Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2011
Conclusão Primária (Real)
1 de janeiro de 2013
Conclusão do estudo (Real)
1 de janeiro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
20 de maio de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de maio de 2011
Primeira postagem (Estimativa)
24 de maio de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
28 de agosto de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2013
Última verificação
1 de agosto de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CogMCI study
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