- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00526942
Behavioral and Physiological Effects of Visual Training
Computer-Based Cognitive Training in Normal Healthy Aging: Pilot Study of Behavioral and Physiological Effects of Visual Sweeps Training Exercise, 2-Arm Model
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Virtually all adults will suffer a decline in their cognitive capacities to some degree. Typically, cognitive decline is characterized by a slow, progressive decline in abilities (frequently in memory, attention, inhibition and speed of processing) relative to younger adults, commonly called normal aging, age-associated memory impairment, age-consistent memory impairment, benign senescent forgetfulness, late-life forgetfulness, ageing-associated cognitive decline, and the preferred term, age-related cognitive decline (ARCD) As virtually all adults experience a reduction in their cognitive abilities with age, ARCD has generally been considered to be a normal, inevitable, and irreversible part of aging; and the extremely severe forms of pathological cognitive decline (e.g., Alzheimer's disease, AD) have dominated therapeutic research in this area. However, ARCD represents an important cause of quality of life decline in almost every older adult, as the impact of forgetfulness and mental slowing increasingly change the abilities of individuals to successfully manage their day-to-day activities. Therapeutic approaches targeting the specific problems of ARCD in normal aging (as opposed to the pathological problems of AD) would unto themselves represent important clinical advances.
This trial investigates the effects of a computer-based visual training exercise built on the principles of positive brain plasticity and designed for use by healthy mature individuals. The program is specifically designed to improve the fidelity of sensory representations in early visual cortex.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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California
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San Francisco Bay Area, California, Estados Unidos, 94104
- Recrutamento
- Posit Science Corporation
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Contato:
- Cate Stasio, BA
- Número de telefone: 3546 4153943100
- E-mail: cate.stasio@positscience.com
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Contato:
- Daniel Tinker, BS
- Número de telefone: 3541 415-394-3100
- E-mail: daniel.tinker@positscience.com
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Investigador principal:
- Joseph L Hardy, PhD
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Subinvestigador:
- Daniel Tinker, BS
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 60 or older at the time of consent.
- Mini-Mental Status Examination (MMSE) score of 26 or higher.
- Adequate visual capacity adequate to read.
- Adequate hearing capacity.
- Willing and able to commit to study time requirements.
Exclusion Criteria:
- Self-report of current diagnosis or history of major neurological illness.
- Self-report of current diagnosis or history of psychiatric illness. c. History of psychiatric hospitalization in the past twenty years.
- History of a stroke, transient ischemic attack (TIA) or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems. - Fibromyalgia or symptoms of severe tremor.
- Self-report of current substance abuse, including alcoholism.
- Current useof medications with substantial CNS effects. Inappropriate behaviors during screening or baseline visits.
- Inability to perform behavioral evaluations.
- Participant is not capable of giving informed consent or unable to comprehend and/or follow instructions.
- Participant is enrolled in a concurrent clinical study that could affect the outcome of this study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: I
No contact control (NCC)
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Experimental: II
Computerized, SAAGE-designed, visual memory-based cognitive training
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Training sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Improvement in visual memory assessment after training or no-contact period.
Prazo: 6-8 weeks
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6-8 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Improvement on at least 1 of the Computerized Visual Attention, Speed and Memory Tests conducted.
Prazo: 6-8 weeks
|
6-8 weeks
|
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Improvement on the computerized cognitive assessments.
Prazo: 6-8 weeks
|
6-8 weeks
|
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Improvement on exercise-based assessments.
Prazo: 6-8 weeks
|
6-8 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joseph L Hardy, PhD, Posit Science Corporation
Publicações e links úteis
Publicações Gerais
- Bischkopf J, Busse A, Angermeyer MC. Mild cognitive impairment--a review of prevalence, incidence and outcome according to current approaches. Acta Psychiatr Scand. 2002 Dec;106(6):403-14. doi: 10.1034/j.1600-0447.2002.01417.x.
- Fillit HM, Butler RN, O'Connell AW, Albert MS, Birren JE, Cotman CW, Greenough WT, Gold PE, Kramer AF, Kuller LH, Perls TT, Sahagan BG, Tully T. Achieving and maintaining cognitive vitality with aging. Mayo Clin Proc. 2002 Jul;77(7):681-96. doi: 10.4065/77.7.681.
- Ahissar E, Nagarajan S, Ahissar M, Protopapas A, Mahncke H, Merzenich MM. Speech comprehension is correlated with temporal response patterns recorded from auditory cortex. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13367-72. doi: 10.1073/pnas.201400998.
- Park HL, O'Connell JE, Thomson RG. A systematic review of cognitive decline in the general elderly population. Int J Geriatr Psychiatry. 2003 Dec;18(12):1121-34. doi: 10.1002/gps.1023.
- Scarmeas N, Stern Y. Cognitive reserve: implications for diagnosis and prevention of Alzheimer's disease. Curr Neurol Neurosci Rep. 2004 Sep;4(5):374-80. doi: 10.1007/s11910-004-0084-7.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- RES-203-2007
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