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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04199767

Registration number

NCT04199767

Ethics application status

Date submitted

12/12/2019

Date registered

16/12/2019

Titles & IDs

Public title

SNIFF Multi-Device Study 2

Scientific title

SNIFF Multi-Device Study 2 - Study of Nasal Insulin to Fight Forgetfulness

Secondary ID [1]

IRB00062612

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild Cognitive Impairment

Cognitive Impairment

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
Treatment: Drugs - 40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)

Experimental: 20 IU Insulin first, then 40 IU Insulin - Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.

Experimental: 40 IU Insulin first, then 20 IU Insulin - Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.

Treatment: Drugs: 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.

Treatment: Drugs: 40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

CSF insulin levels

Timepoint [1]

30 minutes after intervention administration

Secondary outcome [1]

Auditory-Verbal Learning Test (AVLT)

Timepoint [1]

5 minutes before lumbar puncture, and immediately following lumbar puncture.

Eligibility

Key inclusion criteria

* Fluent in English
* Cognitively normal or diagnosis of aMCI
* Stable medical condition for 3 months prior to screening visit
* Stable medications for 4 weeks prior to the screening and study visits
* 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

* A diagnosis of dementia
* History of a clinically significant stroke
* 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
* Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
* Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit.
* History of seizure within past five years
* Pregnancy or possible pregnancy.
* Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa)
* Residence in a skilled nursing facility at screening
* Use of an investigational agent within two months of screening visit
* Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications

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

Crossover

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Suspended

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

16/07/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/10/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

North Carolina

Funding & Sponsors

Primary sponsor type

Other

Name

Wake Forest University Health Sciences

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

The SNIFF Device study will involve using one of three devices to administer insulin through each participant's nose or intra-nasally, accompanied by a lumbar puncture. This goal of this study is to measure how much insulin the device delivers to the cerebrospinal fluid (CSF). In addition, this study will look at the effects of insulin administered intra-nasally on memory, and on blood levels of insulin.

Trial website

https://clinicaltrials.gov/study/NCT04199767

Trial related presentations / publications

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Public notes

 This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts

Principal investigator

Name

Suzanne Craft, PhD

Address

Wake Forest University Health Sciences

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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/NCT04199767

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04199767