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- Klinische Studie NCT01547169
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days (SNIFF-LONG 21)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Washington
-
Seattle, Washington, Vereinigte Staaten, 98108
- VA Puget Sound Health Care System
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: Kochsalzlösung
|
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
Andere Namen:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Andere Namen:
|
Experimental: High Dose Insulin Detemir (20IU bid)
|
10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
Andere Namen:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Verbal Memory Composite
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Neuropsychological Test of Executive Function 1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Suzanne Craft, PhD, VA Puget Sound Health Care System; University of Washington School of Medicine
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neurokognitive Störungen
- Neurodegenerative Krankheiten
- Demenz
- Tauopathien
- Kognitionsstörungen
- Alzheimer Erkrankung
- Kognitive Dysfunktion
- Hypoglykämische Mittel
- Physiologische Wirkungen von Arzneimitteln
- Insulin
- Insulin, Globin Zink
- Insulin Detemir
Andere Studien-ID-Nummern
- 39683-A
- 2P50AG005136-27 (US NIH Stipendium/Vertrag)
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