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Memory Aid by Intranasal Insulin in Diabetes (MemAID)

Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Regular Human Insulin (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Vera Novak, PhD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

Overall contact:
Daniela A Pimentel, Phone: 617-632-8883, Email: dpiment1@bidmc.harvard.edu

Summary

The main purpose of this study is to find the long-term effects of daily administration of 40 IU of intranasal insulin (INI) as compared to placebo (sterile saline) on cognition and memory in people with type 2 diabetes mellitus (DM), and non-diabetic controls over 24 weeks with a follow-up period for 24 weeks. Four groups will be tested: DM group treated with INI; DM group treated with placebo; control group treated with INI and the control group treated with placebo. The INI or placebo will be delivered into the nose. The investigators are interested to see whether INI can improve memory and cognition and blood flow in the brain in the type 2 DM group as compared to placebo and to the non-diabetic group over a long-term period.

Clinical Details

Official title: Memory Advancement by Intranasal Insulin in Type 2 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change in Paired Associates Learning (PAL) total errors (adjusted)

Change in Gait Speed

Change in Fasting glucose

Secondary outcome:

Magnetic Resonance Imaging (MRI) (Vasoreactivity)

Hypoglycemic episodes

Detailed description: The investigators propose a randomized controlled trial determining the long-term effects of intranasal insulin (INI) on cognition and memory in type 2 diabetes (DM) and non-DM groups. The investigators hypothesize that: 1) INI-treated adults with DM have better memory and functioning of specific cognitive domains and faster walking during a dual task than those treated with placebo and the control group; 2) Glycemic and insulin resistance and genetic markers for Alzheimer's disease (Apolipoprotein E4 [ApoE4]) may serve as predictors of positive responses to INI therapy; 3) INI treatment neither adversely affects systemic glycemic levels or the cardiovascular system nor causes weight gain. Aim 1: To determine whether INI-treated type 2 DM adults have a) better memory and functioning of specific cognitive domains and b) faster dual-task gait speed and better daily living functioning than the placebo-treated and non-DM groups. Four groups will be tested: 100 DM subjects treated with insulin; 100 DM subjects treated with placebo; 100 control subjects treated with INI and 100 control subjects treated with placebo. The investigators will conduct a randomized, double-blind, placebo-controlled study in 200 older adults with type 2 DM and 200 non-DM controls examining whether 40 IU INI once daily over a 24-week period improves:

- Specific domains of visuospatial attention and memory, verbal learning (primary

outcomes);

- Gait speed during a dual task (which is an excellent predictor of overall health),

daily living functionality, and depression as compared to the DM group receiving sterile saline and the non-DM groups. The non-DM groups will provide reference of INI effects in a clinical phenotype of cognitive decline and insulin resistance that occurs with normal aging. Aim 2: To identify a phenotype and long-term trajectory predicting clinically relevant response to INI therapy based on glycemic control, insulin resistance, endothelial and genetic markers. 1. The investigators will determine a phenotype predicting a clinically relevant response to INI therapy and identify time-dependent trajectories of INI effects on cognition in the DM group vs. the placebo and the non-DM groups. Clinical predictors will be based on associations between cognitive function and/or gait and demographic, glycemic control, insulin resistance, endothelial and genetic (ApoE4) measures. 2. The investigators will evaluate the dose-escalating trajectory of cognition, gait speed, and functionality during the 24 weeks of therapy and 24 weeks post-treatment and their dependence on the above-mentioned factors, and determine the time point when maximum effect was reached. INI therapy response is defined as a clinically relevant improvement on cognitive tests or in gait speed (as a continuous variable) or as responders vs. non-responders as compared to placebo within DM and non-DM groups (as a categorical variable). 3. MRI substudy: The investigators will explore the long-term INI effects on regional perfusion, vasodilatation, and resting functional connectivity in 40 DM and 40 non-DM subjects pre- and post- INI/placebo administration at the beginning and at the end of intervention and their relationships to cognitive outcomes. Regional perfusion and vasodilatation will be measured by pseudo-continuous arterial spin labeling (PCASL) MRI at 3 Tesla, and resting-state functional connectivity will be quantified from low-frequency (0. 01-0. 08 Hz) fluctuations (LFF) of the whole-brain blood-oxygen-level dependent (BOLD) functional Magnetic Resonance Imaging (fMRI). Aim 3: To determine the long-term safety of INI vs. placebo with regard to glycemic control (fasting glucose, hemoglobin A1c [HbA1c], hypoglycemic episodes), vital signs, and body mass. 1. The investigators will obtain measurements of fasting glucose, insulin, vital signs, and body mass at baseline, 2-months, 4-months, and 6-months follow-up and keep weekly logs monitoring glucose and adverse events. 2. Safety substudy: In the first 20 DM patients treated with subcutaneous insulin, the investigators will conduct continuous glucose monitoring (CGM) for 1 week during baseline and during the first week of INI or placebo treatment to evaluate the INI effects on glycemic control, hypoglycemic episodes, and body weight. This study may pave the way to potential treatment and/or cure of DM- and age-related cognitive decline.

Eligibility

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women aged 50-85 years old

- Able to walk for 6 minutes

- Diabetes type 2 (DM) group: diagnosis and treatment for type 2 DM with non-insulin

oral or injectable agents or insulin

- Non-DM group with similar age range as the DM group, non-diabetic fasting plasma

glucose (<126 mg/dL) and hemoglobin A1c (HbA1c) (<6. 5%) Exclusion Criteria:

- Type 1 DM

- Intolerance to insulin

- History of severe hypoglycemia

- Participants who have >1 asymptomatic and/or symptomatic episode of hypoglycemia

(glucose < 70 mg/dL) during continuous glucose monitoring (CGM) or home measurements

- Acute medical condition that required either hospitalization or surgery within the

past 6 months (e. g., severe hypoglycemia, malignancies, myocardial infarction,stroke)

- Severe chronic sinus problems or allergies

- Liver or renal failure or transplant

- Dementia (Mini Mental State Examination [MMSE] scores ≤20)

- Current recreational drug or alcohol abuse

- Morbid obesity (body mass index [BMI] >45)

- Serious systemic disease that would interfere with conduction of clinical trial

- Magnetic Resonance Imaging (MRI) substudy: claustrophobia and implants incompatible

with 3-Tesla MRI

Locations and Contacts

Daniela A Pimentel, Phone: 617-632-8883, Email: dpiment1@bidmc.harvard.edu

Additional Information

Starting date: July 2015
Last updated: April 13, 2015

Page last updated: August 23, 2015

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