Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT01436045
First received: September 16, 2011
Last updated: February 15, 2013
Last verified: February 2013

September 16, 2011
February 15, 2013
September 2011
March 2013   (final data collection date for primary outcome measure)
cognitive performance [ Time Frame: 20 minutes post-intranasal administration ] [ Designated as safety issue: No ]
Chance from post-saline to post-insulin glulisine for each of the following measures: RBANS,Digit Span, Boston Naming and Trail Making tests. The response to intranasal Insulin glulisine will be expressed as a percent change from post-saline [(result post-insulin - result post-saline) / ( results post-saline)] x 100%.
Same as current
Complete list of historical versions of study NCT01436045 on ClinicalTrials.gov Archive Site
olfactory function [ Time Frame: 60 minute post intranasal adminsitration ] [ Designated as safety issue: No ]
Change from post-saline to post-insulin glulisine in immediate Sniff Magnitude Ratio (measured post-dose).
olfactory function [ Time Frame: post intranasal adminsitration ] [ Designated as safety issue: No ]
Change from post-saline to post-insulin glulisine in immediate Sniff Magnitude Ratio (measured post-dose).
Not Provided
Not Provided
 
Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.
A Double-Blind, Placebo-Controlled Single Dose Study of the Safety and Efficacy of Glulisine on Cognitive Function and Memory in Individuals Diagnosed With Probable Mild to Moderate Alzheimer's Disease/Intranasal Insulin Study.

The purpose of this study is to investigate the effect of the rapidly acting intranasal insulin derivative (glulisine) on memory and cognition in 12 patients suffering from mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose study. This study will further assess safety of insulin glulisine as well as the effects of this drug on olfaction.

A single center, phase II randomized, double-blind, placebo-controlled, cross-over study designed to assess the efficacy and safety of intranasally (IN) delivered insulin glulisine versus placebo in patients aged 65-85 with mild-moderate Alzheimer's Disease (AD). Twelve AD subjects (six female and six male) will be randomized to receive a single dose of either 20 IU/IN insulin glulisine or placebo using the MAD 300 device.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Insulin glulisine
    Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)
    Other Name: Apidra
  • Drug: Placebo : Placebo Comparator
    Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)
    Other Name: Saline
  • Experimental: Insulin glulisine
    A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.
    Intervention: Drug: Insulin glulisine
  • Placebo Comparator: Placebo
    A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.
    Intervention: Drug: Placebo : Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subject with a clinical diagnosis of probable AD in accordance with NINCDS-ADRDA criteria and Dementia Rating Scale (McKhann 1984).
  • Subject has a MMSE score of 18-26.
  • Subject has a Hachinski Ischemia Score < 4.
  • Subject is > 65 and <85 years of age.
  • Female subjects must be at least 2 years post menopausal or surgically sterile.
  • The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology.
  • Subject has a dedicated family member /caregiver, who will be able to attend all visits and report on subject's status.
  • Subject and family member/caregiver have both 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.
  • Subject is on a stable dose (≥ 1 months) of a prescribed acetylcholinesterase inhibitor (e.g. donepezil, rivastigmine, galantamine) and / or memantine.
  • Subject must have a brain CT or MRI in the last 2 years, compatible with the diagnosis of probable Alzheimer's Disease.
  • The subject has a CDR ranging from 1 to 2.

Exclusion Criteria:

  • Subject has medical history and/or clinically determined evidence of other CNS disorders including 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.
  • Subject has medical history and/or clinically determined disorders:current B12 deficiency, positive syphilis serology, chronic sinusitis or any untreated thyroid disease, significant head trauma, or history of difficulty with smell and/or taste prior to AD diagnosis.
  • Subject has been diagnosed with any form of diabetes mellitus, actively takes insulin, or has HbA1c > 6.1 % at screening.
  • Subject has history of any of the following: moderate to severe pulmonary disease, 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.
  • Subject is a heavy smoker (defined as having smoked half a pack or more per day in the last 10 years prior to entry in the study).
  • Subject has history of any psychiatric illness, with the exception of major depressive disorder (according to DSM-IV TR) currently in remission or stable with treatment for > 2 years, or any other psychiatric condition that inclusion would pose a safety risk to the subject as determined by Investigator. Patients with active depression (Geriatric Depression Score>9) will be excluded from the study.
  • Subject is currently taking any medications, herbals and food supplements that are medically/clinically as determine 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.
  • Subject has undergone a recent change (< 1 months) in their prescribed acetylcholinesterase inhibitor (e.g. donepezil, rivastigmine, galantamine)or memantine.
  • Subject has current or recent drug or alcohol abuse or dependence as defined by DSM-IV TR.
  • Subject has systolic blood pressure > 160 or < 90 mmHg or diastolic blood pressure > 100 or < 60 mmHg at Screening.
  • Screening laboratory results that are medically relevant, in which inclusion would pose a safety risk to the subject as determined by Investigator.
  • The subject must not have participated in any other research study at least 3 months prior to this study.
  • The subject has an insulin allergy.
  • Subject has a history of significant traumatic brain injury
  • Subject has a history of acute and chronic rhinitis and/or sinusitis.
  • Subject is legally unable to provide informed written consent due to deterioration in cognitive abilities.
Both
65 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01436045
11-111
Yes
HealthPartners Institute for Education and Research
HealthPartners Institute for Education and Research
Not Provided
Principal Investigator: Michael H Rosenbloom, MD HealthPartners Institute for Education and Research
HealthPartners Institute for Education and Research
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP