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- Registre américain des essais cliniques
- Essai clinique NCT01547169
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days (SNIFF-LONG 21)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Washington
-
Seattle, Washington, États-Unis, 98108
- VA Puget Sound Health Care System
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Saline
|
saline, taken twice per day for a 3 week duration
|
Expérimental: Low Dose Insulin Detemir (10IU bid)
|
10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
Autres noms:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Autres noms:
|
Expérimental: High Dose Insulin Detemir (20IU bid)
|
10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
Autres noms:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Verbal Memory Composite
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Neuropsychological Test of Executive Function 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Suzanne Craft, PhD, VA Puget Sound Health Care System; University of Washington School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles neurocognitifs
- Maladies neurodégénératives
- Démence
- Tauopathies
- Troubles cognitifs
- Maladie d'Alzheimer
- Dysfonctionnement cognitif
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Insuline
- Insuline, Globine Zinc
- Insuline Detemir
Autres numéros d'identification d'étude
- 39683-A
- 2P50AG005136-27 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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