Agitation in Dementia, Including Alzheimer's DiseasePhase 3NCT02817906
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
A Phase 3 study testing ITI-007 in people with Agitation in Dementia, Including Alzheimer's Disease, run by Intra-Cellular Therapies, Inc. at 26 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Agitation in Dementia, Including Alzheimer's Disease
- What is being tested?
- ITI-007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 26 sitesUnited States
- Study dates
- 29 Aug 2016to 30 Jan 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of probable Alzheimer's disease
- Clinically significant symptoms of agitation secondary to probable Alzheimer's disease
- Able to attend outpatient clinic visits with primary caregiver
Who cannot join
- Unable to comply with study procedures
- Considered medically inappropriate for study participation
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Berlin, New Jersey
Study site
Brooklyn, New York
Study site
Centerville, Ohio
Study site
Costa Mesa, California
Study site
Dayton, Ohio
Study site
Glendale, California
Study site
Hallandale, Florida
Study site
Hialeah, Florida
Study site
Honolulu, Hawaii
Study site
Irvine, California
Study site
Las Vegas, Nevada
Study site
Lemon Grove, California
Study site
Little Rock, Arkansas
Study site
Long Beach, California
Study site
Marlton, New Jersey
Study site
Miami, Florida
Study site
Oceanside, California
Study site
Orlando, Florida
Study site
Riverside, California
Study site
Rogers, Arkansas
Study site
San Antonio, Texas
Study site
Santa Ana, California
Study site
Staten Island, New York
Study site
Sun City, Arizona
Study site
Suwanee, Georgia
Study site
Toms River, New Jersey
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.
- Being tested
- ITI-007, Placebo
- Medical subject headings
- Aberrant Motor Behavior in Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-007Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ITI-007 | Experimental | 9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks. Receives: Drug: ITI-007 |
| Placebo | Placebo comparator | Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
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.
Measured: 4 weeks (28 Days)
Secondary outcomes (1)
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
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).
Measured: 4 weeks (28 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start29 Aug 2016
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: Pre-specified Interim Analysis Indicated Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Agitation in Dementia, Including Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Kozauer, M.D., Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817906
- Sponsor's protocol ID
- ITI-007-201
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2016
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02817906
- Acronym / sponsor ID
- ITI-007-201
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pre-specified Interim Analysis Indicated Futility
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITI-007 | Experimental | Drug: ITI-0079 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of probable Alzheimer's disease
- Clinically significant symptoms of agitation secondary to probable Alzheimer's disease
- Able to attend outpatient clinic visits with primary caregiver
Key exclusion criteria (2 listed)
- Unable to comply with study procedures
- Considered medically inappropriate for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-007 | Drug | ITI-007 |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Time frame: 4 weeks (28 Days)
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.
1 secondary outcome
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
Time frame: 4 weeks (28 Days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Agitation in Dementia, Including Alzheimer's Disease
Recruiting
Virtual Darkness Theraphy for Agitation in Dementia
Agitation in Dementia, Including Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Kozauer, M.D. study director
Intra-Cellular Therapies, Inc.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ITI-007 in people with Agitation in Dementia, Including Alzheimer's Disease, run by Intra-Cellular Therapies, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) (time frame: 4 weeks (28 Days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.