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CompletedPhase 1 / PHASE2

Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

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.

Asset

ITI-007

Listed sites

1

Recruiting sites

-

Enrollment

35

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE 26

Primary endpoint

•Adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDITI-007-200
NCT IDNCT02078310

Timeline

Milestones

Study start2014-02 (month precision)
Study first posted2014-03-05estimated
Primary completion2014-08actual (month precision)
Study completion2014-11actual (month precision)
Last update posted2017-11-17actual

Assets

Drug assets

ITI-007

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

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

Exclusion criteria

•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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
2
Safety / tolerability / PK
2
Global cognition
1

Global cognition

1 endpoint
Other/protocol endpoint

Exploratory measures of cognitive function

Time frame:Baseline and up to 7 days

descriptive

Behavior / neuropsychiatric

2 endpoints
Other/protocol endpoint

Exploratory measures of agitation

Time frame:Baseline and up to 7 days

descriptive

Other/protocol endpoint

Exploratory measures of subjective sleep

Time frame:Baseline and up to 7 days

descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number of participants with adverse events

Time frame:up to 7 days

event count, event

Secondary/protocol endpoint

Area under the concentration-time curve (AUC)

Time frame:pre-dose and multiple collection points up to 72 h after the last dose

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.