Alzheimer's DiseasePhase 1/2NCT02078310
Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
A Phase 1/2 study testing ITI-007 in people with Alzheimer's Disease, run by Intra-Cellular Therapies, Inc. at 1 site in United States.
Trial summary
A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Nov 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Part 1
- Healthy geriatric volunteers
- MMSE score of >= 26 at screening
- BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening
- Part 2
- Geriatric patients with a clinical diagnosis of dementia
- MMSE score of < 26 at screening
- BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening
Who cannot join
- Any clinically significant illness within 6 months before screening
- Any history of cancer within last 5 years
- History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level
- Any subject considered to be an imminent danger to themselves or others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Escalation for Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia.
A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia
- Conditions
- Alzheimer's Disease
- Being tested
- ITI-007, Placebo
- Keywords
- Dementia,, Healthy, geriatric, volunteers, patients
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-007Drug
ITI-007 for Part 1
PlaceboDrug
ITI-007 for Part 1
ITI-007Drug
ITI-007 for Part 2
PlaceboDrug
Placebo for Part 2
| Study group | Role | What they receive |
|---|---|---|
| ITI-007 Part 1 | Experimental | Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007 Receives: Drug: ITI-007 |
| Placebo Part 1 | Placebo comparator | Part 1: Healthy geriatric volunteers with placebo given Receives: Drug: Placebo |
| ITI-007 Part 2 | Experimental | Part 2: Geriatric patients with dementia with ITI-007 given Receives: Drug: ITI-007 |
| Placebo Part 2 | Placebo comparator | Part 2: Geriatric patients with dementia with placebo given Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
Measured: up to 7 days
Secondary outcomes (1)
Area under the concentration-time curve (AUC)
Measured: pre-dose and multiple collection points up to 72 h after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078310
- Sponsor's protocol ID
- ITI-007-200
- Status last verified
- Nov 2014
- First submitted
- 28 Feb 2014
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Escalation for Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia.
- ClinicalTrials.gov ID
- NCT02078310
- Acronym / sponsor ID
- ITI-007-200
- Conditions
- Alzheimer's Disease
- Keywords
- Dementia,, Healthy, geriatric, volunteers, patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ITI-007 Part 1 | Experimental | Drug: ITI-007Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007 |
| Placebo Part 1 | Placebo comparator | Drug: PlaceboPart 1: Healthy geriatric volunteers with placebo given |
| ITI-007 Part 2 | Experimental | Drug: ITI-007Part 2: Geriatric patients with dementia with ITI-007 given |
| Placebo Part 2 | Placebo comparator | Drug: PlaceboPart 2: Geriatric patients with dementia with placebo given |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Part 1
- Healthy geriatric volunteers
- MMSE score of >= 26 at screening
- BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening
- Part 2
Key exclusion criteria (4 listed)
- Any clinically significant illness within 6 months before screening
- Any history of cancer within last 5 years
- History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level
- Any subject considered to be an imminent danger to themselves or others
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-007ITI-007 for Part 1 | Drug | ITI-007 Part 1 |
| PlaceboITI-007 for Part 1 | Drug | Placebo Part 1 |
| ITI-007ITI-007 for Part 2 | Drug | ITI-007 Part 2 |
| PlaceboPlacebo for Part 2 | Drug | Placebo Part 2 |
Primary outcome
Number of participants with adverse events
Time frame: up to 7 days
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
1 secondary outcome
Area under the concentration-time curve (AUC)
Time frame: pre-dose and multiple collection points up to 72 h after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ITI-007 in people with Alzheimer's Disease, run by Intra-Cellular Therapies, Inc. at 1 site 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (time frame: up to 7 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 17 Nov 2017.