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

NCT01436045 | Completed Phase 2 Results DMC

• 1 other identifier: 11-111
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Memory; Insulin glulisine; Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• Cognitive Performance

  The results are presented as a mean number of correct responses for each cognitive assessment. For each of these, a lower number correct is indicative of a higher cognitive deficit. Ranges are as follows: RBANS List Learning (0-40), RBANS Story Memory (0-24), RBANS Figure Copy (0-20), RBANSLine Orientation (0-20), RBANS Semantic Fluency (0-unlimited), RBANS List Recall (0-10), RBANS List Recognition (0-20), RBANS Story Recall (0-12), RBANS Figure Recall (0-20), Digit Span Forward (0-16), Digit Span Backward (0-16), Boston Naming (0-15).

  20 minutes post-intranasal administration

• Trails B - Seconds

  The results are presented as the number of seconds to complete Trails B. For each of these, a higher number of seconds is indicative of a higher cognitive deficit.

  20 minutes post-intranasal administration

• Trails B - Errors

  The results are presented as the mean sum of the errors during the Trails B assessment For each of these, a higher number of errors is indicative of a higher cognitive deficit.

  20 minutes post-intranasal administration

Secondary Outcomes (1)

• Olfactory Function

  60 minute post intranasal administration

Study Arms (2)

Insulin glulisine

EXPERIMENTAL

A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.

Drug: Insulin glulisine

Saline

PLACEBO COMPARATOR

A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.

Drug: Saline

Interventions

Insulin glulisine DRUG

Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)

Also known as: Apidra

Insulin glulisine

Saline DRUG

Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)

Also known as: salt water

Saline

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female subject with a clinical diagnosis of probable 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 and Dementia Rating Scale (McKhann 1984).
• Mini-Mental State Examination (MMSE) score of 18-26.
• Hachinski Ischemia Score \< 4.
• Age is \> 65 and \<85 years
• Females must be \> 2 years post-menopausal or surgically sterile.
• Must be able to speak, read and understand English in order to comply with testing of cognitive function, memory and physiology.
• Must have a dedicated family member /caregiver, 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.
• On a stable dose (≥ 1 months) of a prescribed acetylcholinesterase inhibitor (e.g. donepezil, rivastigmine, galantamine) and/or memantine.
• A brain CT or MRI in the last 2 years compatible with the diagnosis of probable Alzheimer's Disease.
• A Clinical Dementia Rating (CDR) ranging from 1 to 2.

You may not qualify if:

• Medical history and/or clinically determined evidence of other central nervous system (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.
• Personal 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.
• Diagnosis with any form of diabetes mellitus, actively takes insulin, or has HbA1c \> 6.1 % at screening.
• Heavy smoker (defined as smoking half a pack or more per day in the last 10 years prior to entry in the study).
• Currently taking any medications, herbals and food supplements that are determined by Investigator to interfere with procedural testing of cognitive function as well as ensure study safety.
• Recent change (\< 1 months) in prescribed acetylcholinesterase inhibitor (e.g. donepezil, rivastigmine, galantamine) or memantine.
• Current or recent drug or alcohol abuse or dependence defined by DSM-IV TR.
• Systolic blood pressure \> 160 or \< 90 mmHg or diastolic blood pressure \> 100 or \< 60 mmHg at Screening.
• Screening laboratory results that are medically relevant and which would pose a safety risk to the subject as determined by Investigator.
• Participation in any other research study at least 3 months prior to this study.
• Insulin allergy.
• History of significant traumatic brain injury
• History of acute and chronic rhinitis and/or sinusitis.
• Legally unable to provide informed written consent due to deterioration in cognitive abilities.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Specialty Center - Center for Dementia & Alzheimer's Care

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

insulin glulisine; Sodium Chloride; Fluoridation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Results Point of Contact

• Title: Michael H Rosenbloom, MD
• Organization: HealthPartners Institute for Education and Research

michael.h.rosenbloom@healthpartners.com

6512547900

Study Officials

• Michael H Rosenbloom, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 19, 2015
• Results First Posted: October 19, 2015

Record last verified: 2015-09

Locations

US (1)