Trial · NCT02415556

Memory Aid by Intranasal Insulin in Diabetes (MemAID)

NCT02415556, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2021-09-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Memory Aid by Intranasal Insulin in Diabetes (MemAID). Trials, record NCT02415556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02415556

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Memory Aid by Intranasal Insulin in Diabetes (MemAID)
NCT number: NCT02415556
Status: Completed
Phases: Phase 2
Enrollment: 289 participants, actual
Lead sponsor: Beth Israel Deaconess Medical Center
Conditions: Type 2 Diabetes Mellitus
Interventions: Regular Human Insulin, Placebo
First posted: 2015-04-14
Last updated: 2022-05-19
Results first posted: 2021-09-17

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Gait Speed Normal Walk (cm/s).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Gait speed normal walk (cm/s) - difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Primary	Gait Speed Dual-task (cm/s).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Gait speed dual-task (cm/s) - walking and counting backwards (subtracting 7) difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Primary	Executive Function Composite z Score	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	The executive function composite score was calculated as a sum of Paired Associates Learning (PAL) and Spatial Working Memory (SWM) z-scores (range -2 to +2, 0 indicates the mean; higher score indicates worse outcome). Paired Associates Learning - raw score of Total Errors Adjusted (range 0-120) was converted to z-score. Spatial Working Memory - raw score SWM-Between Errors (range 0-42) and raw score of SWM-Strategy (range 8-56) were converted to z-scores. Executive function composite scores were compared between: Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Primary	Verbal Memory Composite z Score	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Verbal memory composite score was calculated as the sum of Verbal Recognition Memory (VRM) z scores ( 0 indicates the mean; lower score indicates worse outcome). VRM- Free Recall raw score (range 0-12), immediate and delayed VRM-Recognition raw score (range 0-24) were converted to z-scores. Verbal memory composite scores were compared between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Secondary	Fasting Plasma Glucose (mg/dL).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Long-term safety measure of fasting plasma glucose difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Secondary	Weight (kg).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Long-term safety measure of weight difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Other	Cerebral Blood Flow on Magnetic Resonance Imaging (MRI).	At baseline and at V8 (week 24) the last intervention.	Difference in regional cerebral blood flow in right medial prefrontal cortex (MPFC) was measured by pseudo-continuous arterial spin labeling (PCASL) MRI at 3 Tesla in 8 Type 2 Diabetes Mellitus - Insulin participants and 3 Type 2 Diabetes Mellitus - Placebo participants only.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Gait Speed Normal Walk (cm/s).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.	cm/s	MEAN
PRIMARY	Gait Speed Dual-task (cm/s).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.	cm/s	MEAN
PRIMARY	Executive Function Composite z Score	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.	units on a scale	MEAN
PRIMARY	Verbal Memory Composite z Score	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.	score on a scale	MEAN
SECONDARY	Fasting Plasma Glucose (mg/dL).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.	mg/dL	MEAN
SECONDARY	Weight (kg).	Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).	Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.	kg	MEAN
OTHER_PRE_SPECIFIED	Cerebral Blood Flow on Magnetic Resonance Imaging (MRI).	At baseline and at V8 (week 24) the last intervention.	MRI at 3 Tesla performed in 8 Type 2 Diabetes Mellitus - Insulin participants and 3 Type 2 Diabetes Mellitus - Placebo participants only.	50ml/100g/min	MEAN

Source ClinicalTrials.gov

Results by group76

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Gait Speed Normal Walk (cm/s).	Type 2 Diabetes Mellitus - Insulin	Baseline	112.23	Standard Deviation 22.94	cm/s
Gait Speed Normal Walk (cm/s).	Type 2 Diabetes Mellitus - Placebo	Baseline	103.42	Standard Deviation 21.04	cm/s
Gait Speed Normal Walk (cm/s).	Control - Insulin	Baseline	121.58	Standard Deviation 21.87	cm/s
Gait Speed Normal Walk (cm/s).	Control - Placebo	Baseline	119.51	Standard Deviation 15.61	cm/s
Gait Speed Normal Walk (cm/s).	Type 2 Diabetes Mellitus - Insulin	On-treatment average	112.43	Standard Deviation 22.03	cm/s
Gait Speed Normal Walk (cm/s).	Type 2 Diabetes Mellitus - Placebo	On-treatment average	105.83	Standard Deviation 21.27	cm/s
Gait Speed Normal Walk (cm/s).	Control - Insulin	On-treatment average	123.89	Standard Deviation 23.36	cm/s
Gait Speed Normal Walk (cm/s).	Control - Placebo	On-treatment average	119.44	Standard Deviation 18.60	cm/s
Gait Speed Normal Walk (cm/s).	Type 2 Diabetes Mellitus - Insulin	Post-treatment average	113.12	Standard Deviation 19.60	cm/s
Gait Speed Normal Walk (cm/s).	Type 2 Diabetes Mellitus - Placebo	Post-treatment average	107.27	Standard Deviation 23.16	cm/s

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Type 2 Diabetes Mellitus - Insulin	57
Overall Study	STARTED	Type 2 Diabetes Mellitus - Placebo	58
Overall Study	STARTED	Control - Insulin	65
Overall Study	STARTED	Control - Placebo	64
Overall Study	COMPLETED	Type 2 Diabetes Mellitus - Insulin	32
Overall Study	COMPLETED	Type 2 Diabetes Mellitus - Placebo	37
Overall Study	COMPLETED	Control - Insulin	43
Overall Study	COMPLETED	Control - Placebo	44
Overall Study	NOT COMPLETED	Type 2 Diabetes Mellitus - Insulin	25
Overall Study	NOT COMPLETED	Type 2 Diabetes Mellitus - Placebo	21

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events280

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Flu-like symptoms	General disorders	Type 2 Diabetes Mellitus - Insulin	13	51	17
other	Flu-like symptoms	General disorders	Type 2 Diabetes Mellitus - Placebo	11	55	12
other	Flu-like symptoms	General disorders	Control - Insulin	8	58	12
other	Flu-like symptoms	General disorders	Control - Placebo	17	59	17
other	Fall	Injury, poisoning and procedural complications	Type 2 Diabetes Mellitus - Insulin	6	51	6
other	Fall	Injury, poisoning and procedural complications	Type 2 Diabetes Mellitus - Placebo	3	55	4
other	Fall	Injury, poisoning and procedural complications	Control - Insulin	4	58	4
other	Fall	Injury, poisoning and procedural complications	Control - Placebo	4	59	4
other	Diarrhea	Gastrointestinal disorders	Type 2 Diabetes Mellitus - Insulin	2	51	2
other	Diarrhea	Gastrointestinal disorders	Type 2 Diabetes Mellitus - Placebo	7	55	8

1 to 10 of 280Source ClinicalTrials.gov

See all 280 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Type 2 Diabetes Mellitus - Insulin	0	51
Total, all-cause mortality	Type 2 Diabetes Mellitus - Placebo	0	55
Total, all-cause mortality	Control - Insulin	0	58
Total, all-cause mortality	Control - Placebo	0	59
Total, other adverse events	Type 2 Diabetes Mellitus - Insulin	31	51
Total, other adverse events	Type 2 Diabetes Mellitus - Placebo	37	55
Total, other adverse events	Control - Insulin	33	58
Total, other adverse events	Control - Placebo	33	59
Total, serious adverse events	Type 2 Diabetes Mellitus - Insulin	0	51
Total, serious adverse events	Type 2 Diabetes Mellitus - Placebo	1	55

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25249577	BACKGROUND	PubMed
26040423	BACKGROUND	PubMed
27127468	BACKGROUND	PubMed
31923471	BACKGROUND	PubMed
33505777	BACKGROUND	PubMed
33792960	DERIVED	PubMed
35482079	RESULT	PubMed
36539060	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK103902	Memory Advancement by Intranasal Insulin in Type 2 Diabetes (MemAID)	NOVAK, VERA	BETH ISRAEL DEACONESS MEDICAL CENTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2015 to 2019

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Paired Associate Learning	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02415556

GET https://conductscience.org/api/trials/v1/NCT02415556/results?page=2

API reference For AI assistants