Trial Outcomes & Findings for Intranasal Insulin in Frontotemporal Dementia (FTD) (NCT NCT04115384)

Results Overview

Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline and Post Treatment

Results posted on

2023-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin (Novolin-R) Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Insulin in Frontotemporal Dementia (FTD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Post Treatment

Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Feasibility Measured by EXAMINER Battery	3 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The original goal was to include 12 participants. Since this is a feasibility outcome, the analysis population is the original goal total.

Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=12 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Feasibility Measured by Recruitment	3 Participants

PRIMARY outcome

Timeframe: 2 months

Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs)	1 Total number of AEs/SAEs reported

SECONDARY outcome

Timeframe: 2 months

Population: 12 participants were expected. Only 3 participants were able to complete the trial

Number of patients completing the entire study. Range: 0-12. More participants completing the study indicates higher feasibility.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=12 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Feasibility Measured by Completion of Study	3 Participants

SECONDARY outcome

Timeframe: 2 years

Number of patients screen failing during the study. More participants screen failing the study indicates lower feasibility.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Feasibility Measured by Screen Fails	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Total number of unique participants experiencing AEs/SAEs during the course of treatment. More unique participants experiencing AEs/SAEs indicates a less safe treatment.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs)	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Dot counting measures verbal working memory. Participants are asked to count colored shapes on a tables and remember the final total over 6 trials. Scores are totaled as the number of correct answers or the number of answers recalled. Range: 0-27. A higher score indicates better performance.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Working Memory Measured by EXAMINER - Dot Counting	6.33 score on a scale Standard Deviation 3.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Participants are asked to name as many animals as he/she can in 60 seconds. Scores are totaled as the number of animals verbalized. A higher score indicates better performance.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency	-0.33 named animals Standard Deviation 3.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Participants are asked to choose the direction of one the center arrow in a group 5 arrows. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Inhibition by EXAMINER - Flanker	-0.145 score on a scale Standard Deviation 0.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Participants are asked to match stimulus on different parts of a tablet screen. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Inhibition by EXAMINER - Set Shifting	-0.36 change is score on a scale Standard Deviation 0.13

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

A survey about changes in eating behaviors. The sum of frequency times severity of swallowing related questions is the score for this portion. Caregivers of participant are asked to fill this survey out. Range: 0-96. Higher scores indicate higher difficulty swallowing that produces conflict or embarrassment.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Swallowing Subscore	0.67 change in score on a scale Standard Deviation 0.53

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

A survey about changes in eating behaviors. The sum of frequency times severity of appetite related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-96. Higher scores indicate a greater change in appetite that produces conflict or embarrassment.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Appetite Subscore	-0.67 change in score on a scale Standard Deviation 1.53

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

A survey about changes in eating behaviors. The sum of frequency times severity of eating habit related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-72. Higher scores indicate a greater change in eating habits that produces conflict or embarrassment.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Eating Habits Subscore	7 change in score on a scale Standard Deviation 11.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

A survey about changes in eating behaviors. The sum of frequency times severity of food preference related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-84. Higher scores indicate a greater change in food preferences that produces conflict or embarrassment.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Food Preference Subscore	2.67 change in score on a scale Standard Deviation 4.62

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

A survey about changes in eating behaviors. The sum of frequency times severity of other oral behavior related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-60. Higher scores indicate a greater changes that produces conflict or embarrassment.

Outcome measures

Outcome measures
Measure	Insulin (Novolin-R) n=3 Participants Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Other Oral Behaviors Subscore	0.33 change in score on a scale Standard Deviation 3.51

Adverse Events

Insulin (Novolin-R)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Insulin (Novolin-R) n=3 participants at risk Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Respiratory, thoracic and mediastinal disorders Coughing	33.3% 1/3 • Number of events 1 • 2 months

Additional Information

Manager Research Operations

HealthPartners Institute

Phone: 651-495-6363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place