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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05081219




Registration number
NCT05081219
Ethics application status
Date submitted
4/10/2021
Date registered
18/10/2021

Titles & IDs
Public title
SNIFF - Combo INI+EMPA Trial
Scientific title
Study of Nasal Insulin to Fight Forgetfulness - Combination Intranasal Insulin and Empagliflozin Trial
Secondary ID [1] 0 0
IRB00075245
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 0 0
Cognitive Impairment 0 0
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin (Humulin® R U-100)
Treatment: Drugs - Empagliflozin 10 MG
Treatment: Devices - Aptar Pharma CPS Intranasal Delivery Device
Treatment: Drugs - Placebo (Insulin Diluent)
Treatment: Drugs - Placebo (Capsules)

Experimental: Intranasal Insulin and Empagliflozin Placebo - * 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily

Experimental: Empagliflozin and Intranasal Insulin Placebo - * Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily

Experimental: Intranasal Insulin and Empagliflozin - * 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily

Placebo comparator: Placebo - * 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily


Treatment: Drugs: Insulin (Humulin® R U-100)
Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.

Treatment: Drugs: Empagliflozin 10 MG
Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.

Treatment: Devices: Aptar Pharma CPS Intranasal Delivery Device
Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.

Treatment: Drugs: Placebo (Insulin Diluent)
Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.

Treatment: Drugs: Placebo (Capsules)
Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-related Serious Adverse Events as Assessed by CTCAE v5.0
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Change in the Preclinical Alzheimer Cognitive Composite 5 (PACC5) Z-Score
Timepoint [1] 0 0
Baseline to Week 8
Secondary outcome [2] 0 0
Change in the 14-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 14) Score
Timepoint [2] 0 0
Baseline to Week 8
Secondary outcome [3] 0 0
Change in amyloid ß-peptide (Aß) 40 (Aß40) in Cerebrospinal Fluid (CSF)
Timepoint [3] 0 0
Baseline to Week 8
Secondary outcome [4] 0 0
Change in amyloid ß-peptide (Aß) 42 (Aß42) in Cerebrospinal Fluid (CSF)
Timepoint [4] 0 0
Baseline to Week 8
Secondary outcome [5] 0 0
Change in Cerebrospinal Fluid (CSF) Levels of Total Tau
Timepoint [5] 0 0
Baseline to Week 8
Secondary outcome [6] 0 0
Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181
Timepoint [6] 0 0
Baseline to Week 8
Secondary outcome [7] 0 0
Change in Total Cerebral Blood Flow (CBF) Using MRI Pseudocontinuous Arterial Spin Labeling (ASL)
Timepoint [7] 0 0
Baseline to Week 8

Eligibility
Key inclusion criteria
1. Age 55 to 85 (inclusive)
2. Fluent in English
3. Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)
4. Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria
5. Stable medical condition for 3 months prior to screening visit
6. Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician)
7. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A diagnosis of dementia other than Alzheimer's disease (AD)
2. History of a clinically significant stroke
3. Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
4. Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus
5. Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit
6. History of seizure within past five years
7. Pregnancy or possible pregnancy
8. Use of anticoagulants, unless documentation received from prescribing clinician that anticoagulant medication can be held before LP, and approved by study clinician
9. Residence in a skilled nursing facility at screening
10. Use of an investigational agent within two months of screening visit
11. Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case by case basis by the study physician)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/09/2024
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
Wake Forest University Health Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suzanne Craft, PhD
Address 0 0
Wake Forest University Health Sciences / Wake Forest School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05081219