Trial Outcomes & Findings for ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease (NCT NCT02817906)
NCT ID: NCT02817906
Last Updated: 2021-06-29
Results Overview
The Cohen-Mansfield Agitation Inventory-Community Version is a 37-item scale for identifying and quantifying agitated behaviors in elderly persons in a community setting. Each item is rated from 1='Never' to 7='Several Times Per Hour'. Each category contains a pre-specified subset of the CMAI-C items. The score of each category is the sum of the CMAI-C items included in that category: Aggressive Behavior-Sum of 9 CMAI-C items, ranges from 9 to 63; Non-Aggressive Agitated Behavior-Sum of 6 CMAI-C items, ranges from 6 to 42; Verbally Agitated Behavior-Sum of 4 CMAI-C items, ranges from 4 to 28.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
177 participants
Primary outcome timeframe
4 weeks (28 Days)
Results posted on
2021-06-29
Participant Flow
Participant milestones
| Measure |
ITI-007 9 mg
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
ITI-007(lumateperone tosylate) 9 mg is equivalent to 6 mg lumateperone, the free base or active moiety.
|
Placebo
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
89
|
|
Overall Study
COMPLETED
|
70
|
84
|
|
Overall Study
NOT COMPLETED
|
16
|
5
|
Reasons for withdrawal
| Measure |
ITI-007 9 mg
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
ITI-007(lumateperone tosylate) 9 mg is equivalent to 6 mg lumateperone, the free base or active moiety.
|
Placebo
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
9 mg ITI-007
n=86 Participants
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
|
Placebo
n=89 Participants
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
74.1 years
STANDARD_DEVIATION 8.61 • n=7 Participants
|
74.8 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
CMAI-C
CMAI-C Aggressive Behavior
|
13.28 units on a scale
STANDARD_DEVIATION 4.51 • n=5 Participants
|
14.08 units on a scale
STANDARD_DEVIATION 5.92 • n=7 Participants
|
13.69 units on a scale
STANDARD_DEVIATION 5.27 • n=5 Participants
|
|
CMAI-C
CMAI-C Non-Aggressive Agitated Behavior
|
17.20 units on a scale
STANDARD_DEVIATION 7.42 • n=5 Participants
|
17.46 units on a scale
STANDARD_DEVIATION 7.05 • n=7 Participants
|
17.33 units on a scale
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
CMAI-C
CMAI-C Verbally Agitated Behavior
|
15.37 units on a scale
STANDARD_DEVIATION 4.95 • n=5 Participants
|
15.65 units on a scale
STANDARD_DEVIATION 5.02 • n=7 Participants
|
15.51 units on a scale
STANDARD_DEVIATION 4.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (28 Days)Population: Intent-to-Treat Set (Study stopped for futility)
The Cohen-Mansfield Agitation Inventory-Community Version is a 37-item scale for identifying and quantifying agitated behaviors in elderly persons in a community setting. Each item is rated from 1='Never' to 7='Several Times Per Hour'. Each category contains a pre-specified subset of the CMAI-C items. The score of each category is the sum of the CMAI-C items included in that category: Aggressive Behavior-Sum of 9 CMAI-C items, ranges from 9 to 63; Non-Aggressive Agitated Behavior-Sum of 6 CMAI-C items, ranges from 6 to 42; Verbally Agitated Behavior-Sum of 4 CMAI-C items, ranges from 4 to 28.
Outcome measures
| Measure |
9 mg ITI-007
n=78 Participants
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
|
Placebo
n=84 Participants
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
|
|---|---|---|
|
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Aggressive Agitated Behavior
|
-1.0 score on a scale
Standard Error 0.37
|
-2.3 score on a scale
Standard Error 0.33
|
|
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Non-Aggressive Agitated Behavior
|
-4.1 score on a scale
Standard Error 0.72
|
-3.9 score on a scale
Standard Error 0.65
|
|
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Verbally Agitated Behavior
|
-2.9 score on a scale
Standard Error 0.49
|
-2.3 score on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: 4 weeks (28 Days)Population: Intent-to Treat Set
The CGI scale for Severity of Illness is a standardized assessment tool to rate the overall severity of illness and efficacy of medication. CGI-S of Agitation and CGI-S of Aggression will be used in this study as a measure of efficacy. Scores on the CGI-S range from 1 (not ill at all) to 7 (among the most extremely ill).
Outcome measures
| Measure |
9 mg ITI-007
n=78 Participants
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
|
Placebo
n=84 Participants
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
CGI-S Aggression
|
-0.4 score on a scale
Standard Error 0.12
|
-0.6 score on a scale
Standard Error 0.10
|
|
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
CGI-S Agitation
|
-0.8 score on a scale
Standard Error 0.11
|
-0.9 score on a scale
Standard Error 0.10
|
Adverse Events
9 mg ITI-007
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
9 mg ITI-007
n=86 participants at risk
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
|
Placebo
n=89 participants at risk
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
0.00%
0/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
1.1%
1/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Investigations
Ammonia Increased
|
1.2%
1/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
0.00%
0/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
Other adverse events
| Measure |
9 mg ITI-007
n=86 participants at risk
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
|
Placebo
n=89 participants at risk
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
4.7%
4/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
0.00%
0/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
4/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
1.1%
1/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
3.5%
3/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
0.00%
0/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
2/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
0.00%
0/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
2.3%
2/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
0.00%
0/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
2.3%
2/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
1.1%
1/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
2/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
2.2%
2/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Nervous system disorders
Somnolence
|
0.00%
0/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
3.4%
3/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/86 • 4 weeks of double blind treatment.
Safety Analysis Set
|
2.2%
2/89 • 4 weeks of double blind treatment.
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place