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ABT-288

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Trials Updated: Jun 6, 2018

ABT-288 development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Apr 2009

ABT-288 target and mechanism

Molecular targetHRH3
Target classAntagonist
ModalitySmall molecule

Also known as ABT-288 Low Dose

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment537

FDA Designations

No designations recorded

ABT-288 clinical trials

ABT-288 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT01077700Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With SchizophreniaCognitive Deficits in Schizophrenia
COMPLETED214 Analytics
NCT01018875Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED242 Analytics
PHASE2COMPLETED
Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Cognitive Deficits in SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Cognition: MCCB
Measurements from screening period through 12-week treatment period
ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
Days -1 to 21
Pharmacokinetics; optional CSF for arms 7, 8 & 9
Days -1 to 21

Secondary Endpoints

Functioning: UPSA-2
Measurements from screening period through 12-week treatment period
Cognition: CANTAB
Measurements from screening period through 12-week treatment period
Symptom Severity: PANSS, NSA-16, CGI-S
Measurements from screening period through 12-week treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-288 Dose 1EXPERIMENTALlow dose of ABT-288
ABT-288 Dose 2EXPERIMENTALhigh dose of ABT-288
Sugar PillPLACEBO_COMPARATORinactive substance
Arm 1, Dose 1, ABT-288EXPERIMENTALLow Dose
Arm 2, Dose 2, ABT-288EXPERIMENTALHigh dose
donepezilACTIVE_COMPARATOR -
1EXPERIMENTALABT-288 vs placebo capsules administered orally once daily for 14 days
2EXPERIMENTALABT-288 vs placebo capsules administered orally once daily for 14 days
3EXPERIMENTALABT-288 vs placebo capsules administered orally once daily for 14 days
4EXPERIMENTALABT288 vs placebo administered orally once daily for 14 days
5EXPERIMENTALABT-288 vs placebo administered orally once daily for 14 days
6EXPERIMENTALABT-288 vs placebo administered orally once daily for 14 days
7EXPERIMENTALABT-288 vs placebo administered orally once daily for 14 days
8EXPERIMENTALABT-288 vs placebo administered orally once daily for 14 days
9EXPERIMENTALABT-288 vs placebo administered orally once daily for 14 days

Interventions

NameTypeDescription
ABT-288 Low DoseDRUG -
PlaceboDRUGinactive substance
ABT-288 High DoseDRUG -
ABT-288DRUGSubjects will take 4 capsules once daily for 12 weeks.
donepezilDRUGSubjects will take 4 capsules once daily for 12 weeks.
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Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview. * Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial S...

Countries:United StatesRussiaUkraine
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Frequently asked questions about ABT-288

What is ABT-288?

ABT-288 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) for neurological conditions. It was studied in Phase 2 clinical trials for Alzheimer's disease and for cognitive deficits in schizophrenia, as well as in schizophrenia itself. It is a histamine H3 receptor (HRH3) antagonist.

What is ABT-288 used for?

ABT-288 was studied for Alzheimer's disease and for cognitive deficits in schizophrenia, with additional Phase 1 work in stable schizophrenia patients. It is not an approved therapy; the trials evaluating it have been completed. Its development focused on cognitive symptoms within these neurological and psychiatric indications.

What does ABT-288 target?

ABT-288 targets HRH3, the histamine H3 receptor, and acts as an antagonist at that receptor. Antagonism of HRH3 is the mechanism explored in its clinical program. The compound is a small molecule and was evaluated in Phase 2 studies for Alzheimer's disease and cognitive deficits in schizophrenia.

Who makes ABT-288?

ABT-288 is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie sponsored the clinical trials evaluating the compound, including the Phase 2 studies in Alzheimer's disease and cognitive deficits in schizophrenia and the Phase 1 study in stable schizophrenia patients.

What phase is ABT-288 in?

ABT-288 reached Phase 2 clinical development. It is an investigational drug and is not an approved treatment. Its Phase 2 program covered Alzheimer's disease and cognitive deficits in schizophrenia, and the trials have been completed. A Phase 1 multiple-dose study in stable schizophrenia patients was also completed.

What clinical trials is ABT-288 in?

ABT-288 has been evaluated in completed trials including NCT01077700, a Phase 2 study in cognitive deficits in schizophrenia with 214 participants in the United States, and NCT01018875, a Phase 2 study in mild-to-moderate Alzheimer's disease with 242 participants in Russia and Ukraine. NCT00888693 was a Phase 1 multiple-dose study in stable schizophrenia patients.

Is ABT-288 the same as ABT-288 Low Dose?

Yes, ABT-288 Low Dose is another name for ABT-288, the investigational HRH3 antagonist developed by AbbVie Inc. (ABBV). Both names refer to the same small molecule studied in Phase 2 trials for Alzheimer's disease and cognitive deficits in schizophrenia, so searches under either name point to the same compound.