Phase 2
N=37
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)
Alzheimer's Disease · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01595646 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Verbal Memory Composite — -.31247583; .33390008; -.05181561 Change in Z score memory composite
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Saline (Drug); Insulin detemir (Drug); Insulin (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal Memory Composite |
-.31247583; .33390008; -.05181561 | — |
| SECONDARY Cerebral Spinal Fluid (CSF) Biomarkers of AD |
331.5; 408.5; 305.5; 384; 381.8; 325 | — |
| SECONDARY Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio |
.27; .23; .27; .30; .23; .23 | — |
| SECONDARY Functional Ability |
7.3; 8.7; 7.7; 7; 9.7; 9.7 | — |
| SECONDARY The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision |
20; 21.6; 19.8; 18.5; 23.4; 21.8 | — |
Summary
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 the 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 study in which participants will receive insulin detemir, regular insulin, or placebo over a four month period. The investigators will test the hypothesis that insulin and insulin detemir will both improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that insulin detemir will have the greatest effect.
Eligibility Criteria
Inclusion Criteria
- Age 50-89
- Diagnosed with mild cognitive impairment, or mild/moderate AD
Exclusion Criteria
- Excessively high or low blood pressure, heart rate
- Pre-existing diabetes not controlled by exercise/diet
- 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
Data sourced from ClinicalTrials.gov (NCT01595646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.