Alzheimer's DiseasePhase 1NCT02220738
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
A Phase 1 study testing ABT-957 in people with Alzheimer's Disease, run by AbbVie at 4 sites in United States.
Trial summary
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ABT-957
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's disease (AD);
- Has a Mini-Mental State Examination total score of 16 to 26;
- Has a Modified Hachinski Ischemia Scale score of ≤ 4;
- Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
- Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
- With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health.
Who cannot join
- Positive screen for drugs of abuse, alcohol or cotinine;
- Females must not have positive results for pregnancy;
- Focal neurological signs on examination;
- Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
- History of any significant neurologic disease other than AD;
- History of head trauma, motor vehicle accident, concussion.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site Reference ID/Investigator# 129545
Glendale, California, 91206
Site Reference ID/Investigator# 129641
New York, New York, 10019
Site Reference ID/Investigator# 129435
Orlando, Florida, 32806
Site Reference ID/Investigator# 144825
Salt Lake City, Utah, 84106
About this study
Official title: A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- ABT-957, Placebo for ABT-957
- Keywords
- Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-957Drug
ABT-957 administered twice-daily for 7 days
Placebo for ABT-957Other
Placebo for ABT-957 administered twice-daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| ABT-957 | Experimental | ABT-957 administered twice-daily for 7 days Receives: Drug: ABT-957 |
| Placebo | Placebo comparator | Placebo administered twice-daily for 7 days Receives: Other: Placebo for ABT-957 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic evaluation of the two ABT-957 diastereomers
maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24)
Measured: Day 7
Number of subjects with adverse events
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
Measured: Routinely for the duration of the study, about 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Slow subject enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nuno Mendonca, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220738
- Sponsor's protocol ID
- M13-334
- Status last verified
- Jul 2021
- First submitted
- 18 Aug 2014
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies. Clin Pharmacol Drug Dev. 2019 Apr;8(3):290-303. doi: 10.1002/cpdd.598. Epub 2018 Jul 27.
PubMed 30052328
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
- ClinicalTrials.gov ID
- NCT02220738
- Acronym / sponsor ID
- M13-334
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow subject enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT-957 | Experimental | Drug: ABT-957ABT-957 administered twice-daily for 7 days |
| Placebo | Placebo comparator | Other: Placebo for ABT-957Placebo administered twice-daily for 7 days |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's disease (AD);
- Has a Mini-Mental State Examination total score of 16 to 26;
- Has a Modified Hachinski Ischemia Scale score of ≤ 4;
- Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
- Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
Key exclusion criteria (6 listed)
- Positive screen for drugs of abuse, alcohol or cotinine;
- Females must not have positive results for pregnancy;
- Focal neurological signs on examination;
- Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
- History of any significant neurologic disease other than AD;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-957ABT-957 administered twice-daily for 7 days | Drug | ABT-957 |
| Placebo for ABT-957Placebo for ABT-957 administered twice-daily for 7 days | Other | Placebo |
Primary outcome
Pharmacokinetic evaluation of the two ABT-957 diastereomers
Time frame: Day 7
maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24)
Number of subjects with adverse events
Time frame: Routinely for the duration of the study, about 7 months
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
Results and safety
The study was stopped early (reason given: Slow subject enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Results publication: PubMed 30052328Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies. Clin Pharmacol Drug Dev. 2019 Apr;8(3):290-303. doi: 10.1002/cpdd.598. Epub 2018 Jul 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuno Mendonca, MD study director
AbbVie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-957 in people with Alzheimer's Disease, run by AbbVie at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow subject enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic evaluation of the two ABT-957 diastereomers (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02220738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.