Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
Condition: Mild Cognitive Impairment; Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Insulin glulisine; Placebo
Intervention description: Bacteriostatic 0.9% Sodium Chloride
Intervention MeSH terms: Insulin glulisine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Memory; Insulin glulisine; Alzheimer's disease; Mild Cognitive Impairment; Intranasal insulin; Cognition Disorders

Summary:

      This study evaluates the safety and effectiveness of intranasal (IN) glulisine in patients
      with amnestic mild cognitive impairment (aMCI) and probable Alzheimer's disease. Half of
      participants will receive IN glulisine, while the other half will receive IN placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject is/has

          -  clinical and research diagnosis of amnestic-MCI OR probable mild AD in accordance with
             National Institute of Neurological and Communicative Disorders and Stroke and the
             Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

          -  Montreal Cognitive Assessment (MoCA) score 18-27

          -  Hachinski Ischemia Score <4

          -  50-90 years of age

          -  Females at least 2 years post-menopausal or surgically sterile

          -  Proficiency in speaking, reading and understanding English

          -  Dedicated family member /caregiver, who will be able to attend all visits and report
             on subject's status

          -  (and family member/caregiver) provided fully informed written consent prior to
             participation. In the event that subject is legally unable to provide informed written
             consent due to deterioration in cognitive abilities, fully informed written consent
             must be provided by a legally authorized representative

          -  If AD, a brain computed tomography (CT) or magnetic resonance imaging (MRI) in the
             initial diagnostic workup or subsequent care that is compatible with the diagnosis of
             probable AD

        Exclusion Criteria:

        Subject has/have/is

          -  medical history and/or clinically determined evidence of other central nervous system
             (CNS) disorders including, but not limited to brain tumor, active subdural hematoma,
             seizure disorder, multiple sclerosis, dementia with Lewy bodies, vascular dementia,
             corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease, multiple
             system atrophy, frontotemporal dementia, normal pressure hydrocephalus, Huntington's
             disease, or Jakob-Creutzfeldt disease presenting as dementia

          -  medical history and/or clinically determined disorders: current B12 deficiency,
             chronic sinusitis, any untreated thyroid disease, significant head trauma and history
             of difficulty with smell and/or taste prior to AD diagnosis

          -  history of any of the following: moderate to severe pulmonary disease, poorly
             controlled congestive heart failure, significant cardiovascular and/or cerebrovascular
             events within previous 6 months, condition known to affect absorption, distribution,
             metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal
             disease or any other clinically relevant abnormality that inclusion would pose a
             safety risk to the subject as determined by investigator

          -  previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other
             anomalies

          -  history of any psychiatric illness, with the exception of major depressive and anxiety
             disorder (according to Diagnostic and Statistical Manual of Mental Disorders, version
             5, Text Revision (DSM-IV TR)) currently in remission or stable with treatment for > 2
             yrs, or any other psychiatric condition that inclusion would pose a safety risk to the
             subject as determined by investigator

          -  currently taking any medications, herbals and food supplements that are
             medically/clinically contraindicated as determined by investigator in order to comply
             with procedural testing of cognitive function as well as ensure study safety. See list
             of prohibited medications and compounds

          -  undergone a recent change (<1mo) in their prescribed acetylcholinesterase inhibitor
             (e.g. donepezil, rivastigmine, galantamine) or memantine.

          -  undergone a recent change (<1mo) in their selective serotonin re-uptake inhibitor
             (SSRI) or anti-depressant medication

          -  current or recent drug or alcohol abuse or dependence as defined by DSM-IV TR

          -  laboratory results that are medically relevant, in which inclusion would pose a safety
             risk to the subject as determined by investigator

          -  participated in any other research study at least 3 mos prior to this study

          -  an insulin allergy