ITI-1284 for Alzheimer's Disease Psychosis (NCT06540833)

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ITI-1284 for Alzheimer's Disease Psychosis (NCT06540833)

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Overview

ITI-1284 is a novel sublingual rapidly disintegrating tablet being developed by Intra-Cellular Therapies, Inc. for the treatment of psychosis associated with Alzheimer's disease (AD). This is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 in patients with AD psychosis[@clinicaltrialsgov].

Intra-Cellular Therapies is best known for developing cariprazine (Vraylar®), an FDA-approved antipsychotic for schizophrenia, bipolar disorder, and major depressive disorder. This trial represents their entry into the Alzheimer's disease psychosis (ADP) space[@itcinc].

Alzheimer's disease psychosis affects approximately 25-50% of patients with Alzheimer's disease, manifesting as visual or auditory hallucinations, delusions, and other psychotic symptoms. This represents a significant unmet medical need with no FDA-approved treatments specifically for ADP[@ipapsychosis2024].

Trial Information

| Attribute | Details |
|-----------|---------|
| NCT Number | NCT06540833 |
| Sponsor | Intra-Cellular Therapies, Inc. |
| Drug | ITI-1284 |
| Phase | Phase 2 |
| Indication | Psychosis Associated with Alzheimer's Disease |
| Status | Recruiting |
| Start Date | August 15, 2024 |
| Primary Completion | September 2027 (estimated) |
| Estimated Completion | October 2027 |
| Total Participants | 370 (estimated) |
| Study Design | Randomized, double-blind, placebo-controlled, parallel-group |

Mechanism of Action

Drug Profile

...

Overview

ITI-1284 is a novel sublingual rapidly disintegrating tablet being developed by Intra-Cellular Therapies, Inc. for the treatment of psychosis associated with Alzheimer's disease (AD). This is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 in patients with AD psychosis[@clinicaltrialsgov].

Intra-Cellular Therapies is best known for developing cariprazine (Vraylar®), an FDA-approved antipsychotic for schizophrenia, bipolar disorder, and major depressive disorder. This trial represents their entry into the Alzheimer's disease psychosis (ADP) space[@itcinc].

Alzheimer's disease psychosis affects approximately 25-50% of patients with Alzheimer's disease, manifesting as visual or auditory hallucinations, delusions, and other psychotic symptoms. This represents a significant unmet medical need with no FDA-approved treatments specifically for ADP[@ipapsychosis2024].

Trial Information

| Attribute | Details |
|-----------|---------|
| NCT Number | NCT06540833 |
| Sponsor | Intra-Cellular Therapies, Inc. |
| Drug | ITI-1284 |
| Phase | Phase 2 |
| Indication | Psychosis Associated with Alzheimer's Disease |
| Status | Recruiting |
| Start Date | August 15, 2024 |
| Primary Completion | September 2027 (estimated) |
| Estimated Completion | October 2027 |
| Total Participants | 370 (estimated) |
| Study Design | Randomized, double-blind, placebo-controlled, parallel-group |

Mechanism of Action

Drug Profile

ITI-1284 is a sublingual rapidly disintegrating tablet administered at doses of 10 mg or 20 mg once daily. The specific molecular target and mechanism of action have not been fully disclosed, but the development suggests it targets neuropsychiatric symptoms in AD.

Sublingual Administration Advantages

The sublingual formulation offers several advantages for the AD psychosis population:

Rapid onset: Direct absorption through oral mucosa bypasses first-pass metabolism

Ease of administration: Rapidly disintegrating tablets are easier for patients with swallowing difficulties

Improved compliance: Once-daily dosing with sublingual administration may improve adherence

Reduced GI side effects: Bypasses some gastrointestinal tract exposure

Molecular Mechanism

Mermaid diagram (expand to render)

Comparison with Other AD Psychosis Treatments

| Drug | Company | Formulation | Phase | Status |
|------|---------|-------------|-------|--------|
| ITI-1284 | Intra-Cellular Therapies | Sublingual tablet | Phase 2 | Recruiting |
| ACP-204 | ACADIA Pharmaceuticals | Oral | Phase 2/3 | Recruiting |
| Pimavanserin | ACADIA | Oral | Phase 3 | FDA Approved (PDP only) |
| Risperidone | Generic | Oral | Generic | Off-label |

Trial Design

Study Structure

This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study conducted in three periods:

Period 1: Screening (up to 4 weeks)

Patient eligibility assessment
Confirmation of AD diagnosis
Baseline psychosis evaluation

Patients randomized 1:1 to ITI-1284 or placebo
Flexible dosing: 10 mg or 20 mg once daily
Efficacy and safety assessments

Period 3: Safety Follow-up (30 days)

Post-treatment safety follow-up visit
Approximately 30 days after last dose

Key Study Parameters

| Parameter | Details |
|-----------|---------|
| Randomization | 1:1 (ITI-1284 : Placebo) |
| Treatment Duration | 6 weeks |
| Masking | Quadruple (participant, care provider, investigator, outcomes assessor) |
| Allocation | Randomized, parallel-group |
| Primary Endpoint | Change from baseline in BEHAVE-AD psychosis subscale at Week 6 |

Efficacy Endpoints

Primary Endpoint

BEHAVE-AD psychosis subscale score change from baseline at Week 6

The BEHAVE-AD is a comprehensive rating scale for behavioral symptoms in AD that includes:

Paranoid and delusional ideations domain: 7 items
Hallucinations domain: 5 items
Scoring: 0 (not present) to 3 (present, generally with emotional and physical component)
Maximum psychosis subscale score: 36 points[@behavead]

Secondary Endpoints

Clinical Global Impression - Severity (CGI-S) score at Week 6[@cgis]
Safety and tolerability assessments
Pharmacokinetic evaluations

Patient Population

Inclusion Criteria

Able to understand the nature of the trial and provide informed consent (or LAR consent)

Meets clinical criteria for AD based on 2011 NIA-AA criteria AND either:

High likelihood for amyloid pathology confirmed by blood-based biomarker at Screening; OR
Documented confirmation of AD by CSF biomarker or amyloid PET brain scan

3. Meets criteria for psychosis per IPA provisional consensus definition at Screening and Baseline

Scoring ≥2 on any item of BEHAVE-AD Part A (Paranoid and Delusional Ideation) or Part B (Hallucinations) at Screening and Baseline

CGI-S score ≥4 at Screening and Baseline

MMSE-2:SV score of 6-24 at Screening

Has a designated caregiver

Exclusion Criteria

Psychotic symptoms primarily attributable to delirium, substance abuse, or another general-medical condition

Psychiatric diagnoses including schizophrenia, schizoaffective disorder, bipolar disorder

Risk for suicidal behavior or suicide attempts within 2 years

Unable to discontinue other drugs with psychotropic properties

Hospitalized or receiving skilled nursing care

Significant unstable medical conditions

In hospice or end-of-life care

Key Eligibility Summary

| Parameter | Requirement |
|-----------|-------------|
| Age | ≥55 years |
| Diagnosis | Alzheimer's disease with psychosis |
| MMSE Score | 6-24 (inclusive) |
| BEHAVE-AD | ≥2 on psychosis items |
| CGI-S | ≥4 |
| Caregiver | Required |

Safety Considerations

Expected Adverse Effects

Based on the drug class and patient population, potential adverse effects may include:

Gastrointestinal: Nausea, dry mouth
CNS: Headache, dizziness, somnolence, sedation
Cardiovascular: Orthostatic hypotension
General: Fatigue, insomnia

Safety Monitoring

The trial includes:

Weekly efficacy and safety assessments during treatment period
30-day safety follow-up after last dose
Independent Data Monitoring Committee (DMC)

Advantages of ITI-1284

Sublingual formulation: Easy administration for patients with swallowing difficulties

Rapidly disintegrating: Quick absorption

Once-daily dosing: Simplified regimen

Flexible dosing: 10 mg or 20 mg based on response and tolerability

No dopamine blockade: Lower risk of extrapyramidal symptoms

Clinical Development Context

Unmet Need in AD Psychosis

Alzheimer's disease psychosis represents a significant challenge in neurodegenerative disease care:

Prevalence: 25-50% of AD patients develop psychosis
Impact:
Faster cognitive decline
Earlier nursing home placement
Increased mortality risk
Severe caregiver burden
Treatment gap: No FDA-approved treatments specifically for ADP

Current Treatment Landscape

| Treatment | Limitations |
|-----------|-------------|
| Risperidone | Extrapyramidal symptoms, stroke risk in elderly |
| Quetiapine | Sedation, metabolic effects |
| Aripiprazole | Limited efficacy data in ADP |
| Pimavanserin | FDA-approved only for Parkinson's disease psychosis |

Sites and Recruitment

The trial is actively recruiting at multiple sites across:

United States

California: Anaheim, Costa Mesa, Lafayette, Newport Beach, Orange
Florida: Brandon, Coral Springs, Delray Beach, Doral, Homestead, Maitland, Miami (6 locations), Orlando, Sarasota, Tampa (2 locations)
New Jersey: Toms River
North Carolina: Charlotte
Texas: Cypress, San Antonio
Washington: Bellevue

International Sites

Bulgaria: Blagoevgrad, Cherven Bryag, Sofia (4 locations), Stara Zagora, Vratsa
Croatia: Zagreb (3 locations)
Czech Republic: Brno (2 locations), Hradec Králové, Prague
Poland: Bydgoszcz, Ścinawa
Romania: Bucharest (4 locations), Galati, Sibiu
Serbia: Belgrade, Kovin, Kragujevac, Niš, Novi Kneževac
Slovakia: Banská Bystrica, Bratislava, Košice (2 locations), Krompachy, Vranov nad Topľou
Spain: Albacete, Madrid (not yet recruiting), Zamora (not yet recruiting), Zaragoza

Contact Information

Phone: +1 (646) 440-9333
Email: ITCIClinicalTrials@itc-inc.com

Cross-Links to NeuroWiki

[Alzheimer's Disease Psychosis](/diseases/alzheimer-disease-psychosis) — Target indication
[Psychosis in Neurodegenerative Diseases](/diseases/psychosis-neurodegenerative) — Disease context
[Intra-Cellular Therapies](/companies/intra-cellular-therapies) — Sponsor](/companies/intra-cellular-therapies)
[Cariprazine](/therapeutics/cariprazine) — Related compound from same company](/therapeutics)
[Pimavanserin](/clinical-trials/pimavanserin-parkinsons-psychosis) — Related compound](/proteins/parkin)
[ACP-204](/clinical-trials/acp-204-alzheimers-psychosis) — Competing AD psychosis drug

External Links

[ClinicalTrials.gov - NCT06540833](https://clinicaltrials.gov/show/NCT06540833)
[Intra-Cellular Therapies Pipeline](https://www.itc-inc.com/pipeline/)](/companies/intra-cellular-therapies)
[BEHAVE-AD Scale](https://pubmed.ncbi.nlm.nih.gov/8123008/)
[IPA Psychosis Definition in NCD](https://pubmed.ncbi.nlm.nih.gov/38489612/)

References

[ClinicalTrials.gov - NCT06540833 (2024)](https://clinicaltrials.gov/show/NCT06540833)

[Intra-Cellular Therapies Corporate Pipeline (2024)](https://www.itc-inc.com/pipeline/)

[International Psychogeriatric Association provisional consensus definition of psychosis in major or mild neurocognitive disorder. Am J Geriatr Psychiatry. 2024 (2024)](https://pubmed.ncbi.nlm.nih.gov/38489612/)

[The Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD). Arch Gen Psychiatry. 1994 (1994)](https://pubmed.ncbi.nlm.nih.gov/8123008/)

[Clinical Global Impression Scale - an overview (n.d.)](https://pubmed.ncbi.nlm.nih.gov/8149188/)

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clinical-trials-iti-1284-alzheimers-psychosis-nct06540833

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📊 Evidence Profile Foundational

Evidence Balance

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Certainty

100%

Debates

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Incoming

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Outgoing

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0 supporting 0 contradicting 0 neutral

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📗 Cite This Artifact

ITI-1284 for Alzheimer's Disease Psychosis (NCT06540833)

Overview

Trial Information

Mechanism of Action

Drug Profile

Overview

Trial Information

Mechanism of Action

Drug Profile

Sublingual Administration Advantages

Molecular Mechanism

Comparison with Other AD Psychosis Treatments

Trial Design

Study Structure

Period 1: Screening (up to 4 weeks)

Period 2: Double-Blind Treatment (6 weeks)

Period 3: Safety Follow-up (30 days)

Key Study Parameters

Efficacy Endpoints

Primary Endpoint

Secondary Endpoints

Patient Population

Inclusion Criteria

Exclusion Criteria

Key Eligibility Summary

Safety Considerations

Expected Adverse Effects

Safety Monitoring

Advantages of ITI-1284

Clinical Development Context

Unmet Need in AD Psychosis

Current Treatment Landscape

Sites and Recruitment

United States

International Sites

Contact Information

Cross-Links to NeuroWiki

External Links

References

💬 Discussion