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A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
CREAD 2: Estudo de Fase III, Multicêntrico, Randomizado, Duplo‑cego, Controlado por Placebo, Grupos Paralelos, de Eficácia e Segurança de Crenezumabe em Pacientes com doença de Alzheimer Prodrômica à Leve.
- Transtorno Neurodegenerativo
- Doença de Alzheimer (DA)
Observe que o status de recrutamento do estudo em seu centro pode ser diferente do status geral do estudo porque alguns centros de estudo podem recrutar mais cedo do que outros.
Status do estudo:
Terminado
Este estudo é realizado em
Cidades
- Distrito Federal
- Minas Gerais
- Paraná
- Rio de Janeiro
- Rio Grande do Sul
- São Paulo
Identificador de estudo:
NCT03114657 2016-003288-20 BN29553
As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.
Resumo do Estudo
Este é um estudo de Fase III, multicêntrico, randomizado, duplo-cego, controlado por placebo, de grupos paralelos para avaliar a segurança e a eficácia de crenezumabe em pacientes com AD prodrômica (pAD) a AD leve (mAD). Os pacientes serão incluídos em um período de tratamento duplo-cego de 100 semanas, por infusão intravenosa [IV] a cada 4 semanas [q4w]) e, uma avaliação final de eficácia e segurança 4 semanas após a última dose do paciente (Semana 105). Os pacientes terão então a opção de entrar no estudo de extensão aberta (OLE), se elegíveis. Os pacientes que não entrarem no OLE terão visitas de acompanhamento adicionais com 16 e 52 semanas após a última dose, principalmente para segurança e também para avaliações limitadas de eficácia.
Hoffmann-La Roche
Patrocinador
Fase 3
Fase
NCT03114657, BN29553, 2016-003288-20
Identificador de estudo
Crenezumab, Placebo
Tratamento
Alzheimer's Disease
Condição
Título
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease
Critérios de elegibilidade
Todos
Gênero
≥ 50 Anos & ≤ 85 Anos
Idade
Não
Voluntários Saudáveis
Critérios de Inclusão
- Weight between 40 and 120 kilograms (Kg) inclusive
- Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
- Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
- Fluency in the language of the tests used at the study site
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
- Demonstrated abnormal memory function at screening (up to 4 weeks before screening begins) or screening (FCSRT cueing index =<0.67 AND free recall =<27)
- Screening mini mental state examination (MMSE) score of greater than or equal to (>=) 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
- If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening
- Participant must have completed at least 6 years of formal education after the age of 5 years
Critérios de Exclusão
- Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
- History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
- At risk of suicide in the opinion of the investigator
- Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
- Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
- Uncontrolled hypertension
- Screening hemoglobin A1c (HbA1C) >8%
- Poor peripheral venous access
- History of cancer except:
If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
For the latest version of this information please go to www.forpatients.roche.com
