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Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days (SNIFF-LONG 21)

17 de diciembre de 2012 actualizado por: Suzanne Craft, University of Washington
The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment (aMCI). The rationale for these studies is derived from growing evidence that insulin contributes to multiple brain functions, and that insulin dysregulation can contribute to AD pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have beneficial effects on brain function. Intranasal administration of insulin increases insulin signaling in brain without raising peripheral levels and causing hypoglycemia. Insulin detemir is an insulin analogue that may have better action in brain than other insulin formulations because of its albumin binding properties. The investigators will test the therapeutic effects of intranasally-administered insulin detemir in a dose-finding study in which participants will receive one of two doses of insulin detemir or placebo for a three week period. The investigators will test the hypothesis that either dose will improve memory and daily functioning in persons with AD/aMCI compared with placebo.

Descripción general del estudio

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:

  1. 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).
  2. 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

Intervencionista

Inscripción (Actual)

60

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Washington
      • Seattle, Washington, Estados Unidos, 98108
        • VA Puget Sound Health Care System

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 89 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
saline, taken twice per day for a 3 week duration
Experimental: Low Dose Insulin Detemir (10IU bid)
10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
  • Levémir
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
  • Levémir
Experimental: High Dose Insulin Detemir (20IU bid)
10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
  • Levémir
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Otros nombres:
  • Levémir

¿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
The composite will consist of the weighted sum of Immediate + Delayed Story Recall and Immediate +Delayed List Recall
Change from Baseline in Verbal Memory at 3 Weeks

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
Computerized Dot Counting Test (test of executive functioning)
Change from Baseline in Executive Functioning at 3 Weeks
Glucose Tolerance
Periodo de tiempo: Change from Baseline in Glucose Tolerance at 3 Weeks
Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance
Change from Baseline in Glucose Tolerance at 3 Weeks
Functional Ability
Periodo de tiempo: Change from Baseline in Functional Ability at 3 Weeks
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.
Change from Baseline in Functional Ability at 3 Weeks
Plasma biomarkers of AD
Periodo de tiempo: Change from Baseline in Plasma Biomarkers at 3 Weeks
Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.
Change from Baseline in Plasma Biomarkers at 3 Weeks
Neuropsychological Test of Executive Functioning 2
Periodo de tiempo: Change from Baseline in Executive Functioning at 3 Weeks
Computerized Stroop Test
Change from Baseline in Executive Functioning at 3 Weeks
Neuropsychological Tests of Visual Working Memory
Periodo de tiempo: Change from Baseline in Visual Working Memory at 3 Weeks
Benton Visual Retention Test Form F&G (a test of visual working memory)
Change from Baseline in Visual Working Memory at 3 Weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Suzanne Craft, PhD, VA Puget Sound Health Care System; University of Washington School of Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2011

Finalización primaria (Actual)

1 de diciembre de 2012

Finalización del estudio (Actual)

1 de diciembre de 2012

Fechas de registro del estudio

Enviado por primera vez

7 de febrero de 2012

Primero enviado que cumplió con los criterios de control de calidad

6 de marzo de 2012

Publicado por primera vez (Estimar)

7 de marzo de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de diciembre de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

17 de diciembre de 2012

Última verificación

1 de diciembre de 2012

Más información

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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