Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
15 de setembro de 2016 atualizado por: NYU Langone Health
Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial
The purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe Alzheimer's disease.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Presently some 4.5 million people are afflicted with Alzheimer's disease in the United States. At present pharmacologic treatment, although beneficial, is not curative. Certain nonpharmacologic treatments have assisted caregivers of AD patients by reducing their stress and burden, and others have aided patients, by improving their mood and physical functioning. Comprehensive, individualized approaches to improving Alzheimer's patients' symptomatology and caregiver stress and burden have not been systematically investigated in Alzheimer's patient care. This study seeks to train and counsel caregivers as well as develop an individualized, comprehensive management program that will seek to enhance the functioning of each patient participant.
Patients are randomly placed into one of two groups. Both groups receive memantine and comprehensive evaluations at baseline, 4, 12,28 and 52 weeks. Additionally, group 1 receives an individualized management program, which consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Tipo de estudo
Intervencional
Inscrição (Real)
20
Estágio
- Fase 4
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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New York
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New York, New York, Estados Unidos, 10016
- Fisher Alzheimer's Program, New York University School of Medicine
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patients, 50 years of age or greater, residing in the community
- Presence of a family and/or professional caregiver willing and able to participate in all aspects of this study
- A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al., Neurology,1984;34: 939-944) criteria
- A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA diagnostic criteria for Alzheimer's disease
- Mini-Mental State Examination scores of 3-14
- Global Deterioration Scale stages of 5 or 6
- A stage of 6a or greater on the Functional Assessment Staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living
Exclusion Criteria:
- Non-English speaking patients and/or caregivers
- Subjects with a diagnosis of dementia due to conditions other than Alzheimer's disease.
- Subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified Hachinski Ischemic Rating scale
- Patients with a major depressive disorder
- Patients with clinically significant laboratory abnormalities
- Patients receiving investigational pharmacologic agents
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
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group 1
Individualized Management including caregiver training and Memantine
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Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Outros nomes:
Patients receive 10 milligrams of memantine twice daily.
Outros nomes:
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Comparador Ativo: Group 2
Only Memantine
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Patients receive 10 milligrams of memantine twice daily.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
Prazo: Baseline to 28 weeks
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CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse
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Baseline to 28 weeks
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Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
Prazo: Baseline to 52 weeks
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CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse
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Baseline to 52 weeks
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Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
Prazo: Baseline to 28 weeks
|
The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver.
Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.
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Baseline to 28 weeks
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Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
Prazo: Baseline to 52 weeks
|
The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver.
Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.
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Baseline to 52 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline of the Severe Impairment Battery (SIB)
Prazo: Baseline to 28 weeks
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The SIB evaluates cognitive performance.
It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction.
Scores range from 0 (greatest impairment) to 100 (least impairment).
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Baseline to 28 weeks
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Change From Baseline of the Severe Impairment Battery (SIB)
Prazo: Baseline to 52 weeks
|
The SIB evaluates cognitive performance.
It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction.
Scores range from 0 (greatest impairment) to 100 (least impairment).
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Baseline to 52 weeks
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Change From Baseline of the Mini-Mental State Examination (MMSE)
Prazo: Baseline to 28 weeks
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The MMSE is a graded on a 30 point scale that measures cognitive functioning.
A lower score indicates a higher level of impairment.
Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.
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Baseline to 28 weeks
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Change From Baseline of the Mini-Mental State Examination (MMSE)
Prazo: Baseline to 52 weeks
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The MMSE is a graded on a 30 point scale that measures cognitive functioning.
A lower score indicates a higher level of impairment.
Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.
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Baseline to 52 weeks
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Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
Prazo: Baseline to 28 weeks
|
The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2. The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described) |
Baseline to 28 weeks
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Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
Prazo: Baseline to 52 weeks
|
The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2. The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described) |
Baseline to 52 weeks
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Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
Prazo: Baseline to 28 weeks
|
The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating.
Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed.
Possible total scores range from 0 to 297.
The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver).
Global rating was not analyzed for this study.
The higher the score the worse the outcome.
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Baseline to 28 weeks
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Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
Prazo: Baseline to 52 weeks
|
The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating.
Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed.
Possible total scores range from 0 to 297.
The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver).
The higher the score the worse the outcome.
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Baseline to 52 weeks
|
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
Prazo: Baseline to 28 weeks
|
The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react.
Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset).
Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver.
Possible scores range from 0 to 96.
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Baseline to 28 weeks
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
Prazo: Baseline to 28 weeks
|
The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react.
Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset).
Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver.
Possible scores range from 0 to 96.
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Baseline to 28 weeks
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
Prazo: Baseline to 52 weeks
|
The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react.
Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset).
Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver.
Possible scores range from 0 to 96.
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Baseline to 52 weeks
|
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
Prazo: Baseline to 52 weeks
|
The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react.
Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset).
Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver.
Possible scores range from 0 to 96.
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Baseline to 52 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Barry Reisberg, M.D., NYU Langone Health
- Diretor de estudo: Sunnie Kenowsky, D.V.M., NYU Langone Health
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015.
- Reisberg B, Kenowsky S, Franssen EH, Auer SR, Souren LE. Towards a science of Alzheimer's disease management: a model based upon current knowledge of retrogenesis. Int Psychogeriatr. 1999 Mar;11(1):7-23. doi: 10.1017/s1041610299005554.
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 agosto de 2006
Conclusão Primária (Real)
1 de novembro de 2011
Conclusão do estudo (Real)
1 de novembro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de julho de 2005
Primeira postagem (Estimativa)
19 de julho de 2005
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
25 de outubro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de setembro de 2016
Última verificação
1 de setembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Distúrbios Neurocognitivos
- Doenças Neurodegenerativas
- Demência
- Tauopatias
- Doença de Alzheimer
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Antagonistas de Aminoácidos Excitatórios
- Agentes Aminoácidos Excitatórios
- Agentes de Dopamina
- Agentes antiparkinsonianos
- Agentes Antidiscinesia
- Memantina
Outros números de identificação do estudo
- H12444-01 A
- NAM MD 18 (Número de outro subsídio/financiamento: Forest Laboratories)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .