Recent Updates
Recently added Catalysts

AZD1446

Phase 2

Adult ADHD | Small molecule | Psychiatry |AstraZeneca PLC|Trials Updated: Sep 2, 2011

AZD1446 development status

Highest phase Phase 2
Registered trials 11 across 1 sponsor since Dec 2008

AZD1446 target and mechanism

Molecular targetCHRNB2, CHRNA4
Target classAgonist
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment254

FDA Designations

No designations recorded

AZD1446 clinical trials

AZD1446 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT010397014 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's DiseaseMild to Moderate Alzheimer's Disease
COMPLETED99 Analytics
NCT01012375Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.Adult ADHD
COMPLETED135 Analytics
PHASE2COMPLETED
4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease
Mild to Moderate Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.
Adult ADHDUnlock trial analytics

Study Endpoints

Primary Endpoints

Nature and incidence of adverse events
From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.
AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)
The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
qEEG assessed through the absolutes alpha-power of the two occipital leads
In each treatment period (1, 2, 3, 4) the measure will be taken on Day 1 prior to dosing of AZD1446 or placebo and1h, 2h, 3h, 6h, and 24 hour after dosing of AZD1446 or placebo

Secondary Endpoints

To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil
Twice during the study: at Visit 2 and Visit 10.
To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients
Twice during the study: at Visit 8 and Visit 10.
To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC
Baseline assessment at Visit 2 and a follow-up assessment at Visit 10
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD1446 60mg once daily + donepezil 10mg
2EXPERIMENTALAZD1446 60mg three times daily + donepezil 10mg
3EXPERIMENTALAZD1446 30mg three times daily + donepezil 10mg
4PLACEBO_COMPARATORplacebo + donepezil 10mg
AEXPERIMENTALSingle dose of AZD1446 10 mg
BEXPERIMENTALSingle dose of AZD1446 80 mg
CACTIVE_COMPARATORSingle Dose of Donepezil 5 mg
DPLACEBO_COMPARATORSingle dose of placebo to match AZD1446

Interventions

NameTypeDescription
AZD1446DRUGcapsules, oral, 3 times daily
PlaceboDRUGcapsules, oral, 3 times daily, 4 weeks
donepezilDRUGcapsule, single oral dose
Unlock Study Design Details

Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * history of progressive worsening of memory and other cognitive functions for at least 12 months * treatment with stable dose of donepezil (10 mg) for at least 3 months * the patient should have an appropriate caregiver, who is required for all study visits Exclusion Criteria:...

Countries:CzechiaHungarySlovakiaUnited StatesFrance
Unlock Eligibility Criteria

Frequently asked questions about AZD1446

What is AZD1446?

AZD1446 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for psychiatric and cognitive conditions. It has been studied in adult ADHD, cognition, and mild to moderate Alzheimer's disease. It is a Phase 2 candidate and has not been approved for any indication.

What is AZD1446 used for?

AZD1446 has been studied for adult ADHD, cognition, and mild to moderate Alzheimer's disease. It is an investigational drug and is not approved for any of these uses. Clinical testing has included a Phase 2 trial in adult ADHD and a Phase 2 trial in mild to moderate Alzheimer's disease.

What does AZD1446 target?

AZD1446 targets CHRNB2 and CHRNA4, which are nicotinic acetylcholine receptor subunits. It acts as an agonist at these targets. This receptor activity is the basis for its investigation in ADHD and cognitive impairment, though it remains an investigational agent.

Who makes AZD1446?

AZD1446 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trials of AZD1446, including studies in adult ADHD, cognition, and mild to moderate Alzheimer's disease.

What phase is AZD1446 in?

AZD1446 is in Phase 2 development. It has completed Phase 2 trials in adult ADHD and in mild to moderate Alzheimer's disease, as well as a Phase 1 cognition study. It is investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is AZD1446 in?

AZD1446 has completed three trials: NCT01044342, a Phase 1 cognition study in healthy male volunteers in France; NCT01039701, a Phase 2 safety and tolerability study in mild to moderate Alzheimer's disease in Czechia, Hungary, and Slovakia; and NCT01012375, a Phase 2 efficacy and tolerability study in adult ADHD in the United States.