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NCT02078310COMPLETEDanonymous

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.

Sponsor

Source record

Intra-Cellular Therapies, Inc.

Phase

Source record

Phase 1b/2

Modality

AI-normalized

small molecule

Target

AI-normalized

Not specified in the provided data; further research required to identify the precise molecular or mechanistic target profile of ITI-007.

Indication / condition

AI-normalized

Alzheimer's Disease

Intervention

Source record

ITI-007, Placebo, ITI-007, Placebo

Source & freshness

Source record

NCT ID

NCT02078310

Original source

ClinicalTrials.gov

Source last updated

Nov 17, 2017

Ingested at

Jun 16, 2026

Internal sync

Jun 16, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT02078310

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.

Sponsor

Intra-Cellular Therapies, Inc.

Status

COMPLETED

Phase

Phase 1b/2

Condition raw

Alzheimer's Disease

Condition normalized

Alzheimer's Disease

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Not specified in the provided data; further research required to identify the precise molecular or mechanistic target profile of ITI-007.

Target normalized

Not specified in the provided data; further research required to identify the precise molecular or mechanistic target profile of ITI-007.

Interventions

ITI-007, Placebo, ITI-007, Placebo

Public preview

Source record

ITI-007, developed by Intra-Cellular Therapies, Inc., is positioned to address unmet needs in the treatment of dementia, particularly in geriatric patients. The market for dementia therapeutics is significant, with increasing prevalence due to aging populations. Given the dual focus on both healthy geriatric volunteers and dementia patients, this study may provide insights into safety and pharmacokinetics that could enhance market positioning. Competitive analysis should consider existing dementia therapies and emerging candidates, particularly those targeting similar patient demographics. Diligence implications include assessing the potential for ITI-007 to differentiate itself in a crowded market, particularly in terms of safety and tolerability profiles.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

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.

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 16, 2026

NCT ID

NCT02078310

Status

COMPLETED

Phase

Phase 1b/2

Sponsor

Intra-Cellular Therapies, Inc.

Executive brief

Investment-Ready Snapshot

ITI-007, developed by Intra-Cellular Therapies, Inc., is positioned to address unmet needs in the treatment of dementia, particularly in geriatric patients. The market for dementia therapeutics is significant, with increasing prevalence due to aging populations. Given the dual focus on both healthy geriatric volunteers and dementia patients, this study may provide insights into safety and pharmacokinetics that could enhance market positioning. Competitive analysis should consider existing dementia therapies and emerging candidates, particularly those targeting similar patient demographics. Diligence implications include assessing the potential for ITI-007 to differentiate itself in a crowded market, particularly in terms of safety and tolerability profiles.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedNov 17, 2017
Internal syncJun 16, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT02078310

Indication

Alzheimer's Disease

Modality

small molecule

Target

Not specified in the provided data; further research required to identify the precise molecular or mechanistic target profile of ITI-007.

Intervention

ITI-007, Placebo, ITI-007, Placebo

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.