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ABT-288

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment242

FDA Designations

No designations recorded

Clinical trial landscape

ABT-288 · 2 trials · 2 indications

Phase 2 1Phase 1 1
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 of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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

MMSE: Mini Mental Status Exam
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
NPI: Neuropsychiatric Inventory
Day -1, Weeks 4,8, 12/PD
ADCS-ADL: Alzheimer's Disease Cooperative Study
Day -1, Weeks 4,8 & 12/PD
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1, Dose 1, ABT-288EXPERIMENTALLow Dose
Arm 2, Dose 2, ABT-288EXPERIMENTALHigh dose
donepezilACTIVE_COMPARATOR -
sugar pillPLACEBO_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-288DRUGSubjects will take 4 capsules once daily for 12 weeks.
donepezilDRUGSubjects will take 4 capsules once daily for 12 weeks.
placeboDRUGSubjects will take 4 capsules once daily for 12 weeks.
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Eligibility Criteria

Age Range55 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactiv...

Countries:RussiaUkraine
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Frequently asked questions about ABT-288

What is ABT-288 used for?

ABT-288 is an investigational small molecule being developed by AbbVie Inc. for the treatment of schizophrenia and Alzheimer's disease. It has been studied in clinical trials for these neurological conditions, including a Phase 2 study in patients with mild-to-moderate Alzheimer's disease.

Who makes ABT-288?

ABT-288 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie has conducted clinical trials of ABT-288 in schizophrenia and Alzheimer's disease.

What phase is ABT-288 in?

ABT-288 is an investigational drug that has completed Phase 2 clinical development. It is not FDA approved and remains in clinical development. The most advanced study was a Phase 2 trial in Alzheimer's disease, which has been completed.

What clinical trials is ABT-288 in?

ABT-288 has been studied in two completed clinical trials. NCT00888693 was a Phase 1 multiple dose study in stable subjects with schizophrenia. NCT01018875 was a Phase 2 efficacy and safety study in subjects with mild-to-moderate Alzheimer's disease, conducted in Russia and Ukraine.

Is ABT-288 the same as any other drug?

ABT-288 is the investigational code name for this compound developed by AbbVie. No alternative brand names or other designations have been associated with this drug in the available clinical trial information.