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AZD1446

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

AZD1446 · 10 trials · 4 indications

Phase 2 2Phase 1 8
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 Disease
NCT0103970199
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PHASE2COMPLETED
Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.
Adult ADHD
NCT01012375135
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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
To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG.
During the whole study period, ca. 50 days
Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F
Part 1 - 11 days
Part 2 Multiple Dose Administration: - Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ)
Part 2 - 10 days
To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.
During the whole study period, ca. 50 days.
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
To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).
During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38).
Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.
One PET assessment on baseline day and one PET assessment at the drug treatment day
Plasma concentration (Cmax, tmax, AUC)
During time period of the PET assessment
Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers,
during the whole study period, ca 50 days
Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers.
during the whole study period, ca 43 days
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
From first to last visit

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
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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
Cohort 1 (2 arms)EXPERIMENTALPeriod 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions.
Cohort 2 (2 arms)EXPERIMENTALPeriod 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions.
Cohort 3( 2 arms)EXPERIMENTALPeriod 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions.
Cohort 4 (2 arms)EXPERIMENTALPeriod 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions.
Part 2: Extended/Modified releaseEXPERIMENTALExtended/Modified release capsule to be determined
Part 2: PlaceboPLACEBO_COMPARATOR -
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
AZD1446 LowEXPERIMENTALLow dose of AZD1446
AZD1446 HighEXPERIMENTALHigh dose of AZD1446
PlaceboPLACEBO_COMPARATOR -
2-[18F]-F-A85380EXPERIMENTALSingle microdose
AZD1446EXPERIMENTALSingle oral administration
AZD1446 Oral or placeboEXPERIMENTALSingle oral administration of AZD1446 or placebo
AZD1446 Oral, with or without foodEXPERIMENTALSingle oral administration of AZD1446 with or without food

Interventions

NameTypeDescription
AZD1446DRUGcapsules, oral, 3 times daily
PlaceboDRUGcapsules, oral, 3 times daily, 4 weeks
donepezilDRUGcapsule, single oral dose
2-[18F]-F-A85380RADIATIONiv, single dose
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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 StatesJapanSwedenFrance
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Frequently asked questions about AZD1446

What is AZD1446 used for?

AZD1446 is an investigational small molecule being studied for cognition, adult ADHD, healthy volunteers, and mild to moderate Alzheimer's disease. It is in Phase 2 development for these psychiatric and cognitive conditions, though all seven completed trials were Phase 1 studies.

Who makes AZD1446?

AZD1446 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The drug is an investigational small molecule in Phase 2 clinical development for cognition and related conditions.

What phase is AZD1446 in?

AZD1446 is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. All seven completed trials were Phase 1 studies, with no active trials currently listed.

What clinical trials has AZD1446 been in?

AZD1446 has completed seven Phase 1 trials, including NCT00997308, NCT01021189, NCT01044342, and NCT01199315. These studies evaluated safety, tolerability, and pharmacokinetics in healthy volunteers, including elderly and Japanese subjects, and assessed cognition in a male volunteer study.

Is AZD1446 the same as any other drug?

AZD1446 is the sole name provided for this investigational compound. No alternative names have been identified in the available information, so it is not known to be the same as any other marketed or investigational drug.