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- Ensayo clínico NCT01547169
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days (SNIFF-LONG 21)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
It is well-known that insulin, a hormone that is naturally secreted by the pancreas, plays an important physiological role by regulating blood sugar levels in the body. The investigators now know that insulin plays many important roles in the brain as well. Insulin seems to be especially active in the part of the brain that corresponds to learning and memory. Studies have shown that when people have insufficient insulin in the brain (which, for example, is the case with Type-II diabetes), they are increasingly at risk to develop memory problems and Alzheimer's disease. In a past study, the investigators administered intravenous insulin to participants and found that it improves their memory. However, that particular method would not be a practical intervention for people with Alzheimer's disease due to the risk of hypoglycemia or exacerbation of insulin resistance. Instead, the investigators use an "intranasal" method of administration, in which the insulin is inserted into a device, and administered intranasally. In this method, the insulin travels directly to the brain, and bypasses the body. Our past studies have also demonstrated that this can be a reliable way to improve memory, and it does not change the body's blood glucose levels.
In our past studies, the investigators have used regular insulin, which lasts about 3-4 hours and creates a similar "spike" in insulin that one would have after eating a meal. However, in normal physiology, the pancreas also releases small and more constant "pulses" of insulin throughout the day and night, establishing a base level of insulin. Accordingly, several longer-lasting types of insulin are now available that last closer to 10-12 hours, mimicking that base level of insulin. The current study uses a long-lasting type of insulin called "insulin detemir," to determine if learning and memory will benefit from a more constant supplement of insulin. the investigators want to determine whether this treatment can benefit people who already have a memory impairment-either they already have a diagnosis of Alzheimer's disease or are diagnosed with mild cognitive impairment, a condition that precedes Alzheimer's disease, and whether a lower or higher dose of insulin detemir is more effective. The investigators will examine cognition, daily function, and different markers of Alzheimer's disease that are in the blood as outcome measures.
The investigators have these specific aims:
- The investigators will test the hypothesis that compared to placebo, three weeks of treatment with intranasal insulin detemir will improve cognition and function in adults with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
- The investigators will determine which of two doses of intranasal insulin detemir produces the greatest improvement in cognition and daily function relative to placebo for adults with AD or MCI.
To examine these hypotheses, the investigators are recruiting approximately 60 participants who have been diagnosed with AD or MCI. They will be randomly selected to take a lower dose of insulin detemir, a higher dose of insulin detemir, or saline (which is an inactive substance and will serve as a placebo). Cognition and the level of daily function will be tested before they begin the study drug, and after 3 weeks of the study drug. The investigators will also measure glucose tolerance and take blood samples to measure markers of AD in the blood.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98108
- VA Puget Sound Health Care System
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 50-89
- Diagnosed with mild cognitive impairment, or mild/moderate AD
Exclusion Criteria:
- Excessively high or low blood pressure, heart rate
- BMI greater than 34
- Pre-existing diabetes not controlled by exercise
- Previous/current use of insulin
- Significant elevations in lipids, liver enzymes
- Menstrual period within the last 12 months
- Significant neurological or medical disorder (other than AD)
- Significant use of nasal decongestants
- Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Salina
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saline, taken twice per day for a 3 week duration
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Experimental: Low Dose Insulin Detemir (10IU bid)
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10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
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Experimental: High Dose Insulin Detemir (20IU bid)
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10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Verbal Memory Composite
Periodo de tiempo: Change from Baseline in Verbal Memory at 3 Weeks
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The composite will consist of the weighted sum of Immediate + Delayed Story Recall and Immediate +Delayed List Recall
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Change from Baseline in Verbal Memory at 3 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Neuropsychological Test of Executive Function 1
Periodo de tiempo: Change from Baseline in Executive Functioning at 3 Weeks
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Computerized Dot Counting Test (test of executive functioning)
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Change from Baseline in Executive Functioning at 3 Weeks
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Glucose Tolerance
Periodo de tiempo: Change from Baseline in Glucose Tolerance at 3 Weeks
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Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance
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Change from Baseline in Glucose Tolerance at 3 Weeks
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Functional Ability
Periodo de tiempo: Change from Baseline in Functional Ability at 3 Weeks
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Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale.
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Change from Baseline in Functional Ability at 3 Weeks
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Plasma biomarkers of AD
Periodo de tiempo: Change from Baseline in Plasma Biomarkers at 3 Weeks
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Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.
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Change from Baseline in Plasma Biomarkers at 3 Weeks
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Neuropsychological Test of Executive Functioning 2
Periodo de tiempo: Change from Baseline in Executive Functioning at 3 Weeks
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Computerized Stroop Test
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Change from Baseline in Executive Functioning at 3 Weeks
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Neuropsychological Tests of Visual Working Memory
Periodo de tiempo: Change from Baseline in Visual Working Memory at 3 Weeks
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Benton Visual Retention Test Form F&G (a test of visual working memory)
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Change from Baseline in Visual Working Memory at 3 Weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Suzanne Craft, PhD, VA Puget Sound Health Care System; University of Washington School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos neurocognitivos
- Enfermedades neurodegenerativas
- Demencia
- Tauopatías
- Trastornos cognitivos
- Enfermedad de Alzheimer
- Disfunción congnitiva
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Insulina
- Insulina, Globina Zinc
- Insulina Detemir
Otros números de identificación del estudio
- 39683-A
- 2P50AG005136-27 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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