Alzheimer's DiseasePhase 1NCT02573740
Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment
A Phase 1 study testing ABT-957 in people with Alzheimer's Disease and Mild Cognitive Impairment, run by AbbVie at 9 sites in United States.
Trial summary
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- ABT-957
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2015to Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants must have negative results for pregnancy test performed on a serum sample obtained at Screening
- Body Mass Index is 18.0 to 35.0 at Screening
- Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease (AD).
- Meets the NIA-AA core clinical criteria for Mild Cognitive Impairment due to AD
Who cannot join
- Use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration
- Consumption of alcohol within 24 hours prior to study drug administration
- Positive screen for non-prescribed drugs of abuse or alcohol
- The participant has clinically significant abnormal laboratory values at Screening as determined by the investigator
- History of a drug or alcohol abuse within 6 months prior to study drug administration
- Current diagnosis of major depression or other major psychiatric disorder
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Site Reference ID/Investigator# 143182
Cincinnati, Ohio, 45255
Site Reference ID/Investigator# 143180
Cypress, California, 90630
Site Reference ID/Investigator# 149481
Dallas, Texas, 75231
Site Reference ID/Investigator# 143181
Marlton, New Jersey, 08053
Site Reference ID/Investigator# 143254
Orem, Utah, 84058
Site Reference ID/Investigator# 143178
Orlando, Florida, 32806
Site Reference ID/Investigator# 143179
Salt Lake City, Utah, 84107
Site Reference ID/Investigator# 143177
Spokane, Washington, 99202
Site Reference ID/Investigator# 149484
The Villages, Florida, 32162
About this study
Official title: A Study to Evaluate the Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of Multiple Doses of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- ABT-957, Placebo
- Keywords
- Mild Cognitive Impairment, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-957Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| ABT-957 | Experimental | ABT-957 given twice a day for 84 days Receives: Drug: ABT-957 |
| Placebo | Placebo comparator | Placebo given twice a day for 84 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting treatment-emergent adverse events
Measured: For approximately 84 days
Level of spectrin breakdown product-145 (SBDP-145)
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Insufficient target engagement of ABT-957 (preclinical data)
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 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
- NCT02573740
- Sponsor's protocol ID
- M13-730
- Status last verified
- Jul 2021
- First submitted
- 8 Oct 2015
- 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 Study to Evaluate the Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of Multiple Doses of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02573740
- Acronym / sponsor ID
- M13-730
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient target engagement of ABT-957 (preclinical data)
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Oct 2015 (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 is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT-957 | Experimental | Drug: ABT-957ABT-957 given twice a day for 84 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo given twice a day for 84 days |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants must have negative results for pregnancy test performed on a serum sample obtained at Screening
- Body Mass Index is 18.0 to 35.0 at Screening
- Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease (AD).
- Meets the NIA-AA core clinical criteria for Mild Cognitive Impairment due to AD
Key exclusion criteria (6 listed)
- Use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration
- Consumption of alcohol within 24 hours prior to study drug administration
- Positive screen for non-prescribed drugs of abuse or alcohol
- The participant has clinically significant abnormal laboratory values at Screening as determined by the investigator
- History of a drug or alcohol abuse within 6 months prior to study drug administration
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-957 | Drug | ABT-957 |
| Placebo | Other | Placebo |
Primary outcome
Percentage of participants reporting treatment-emergent adverse events
Time frame: For approximately 84 days
Level of spectrin breakdown product-145 (SBDP-145)
Time frame: 84 days
Results and safety
The study was stopped early (reason given: Insufficient target engagement of ABT-957 (preclinical data)). 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
9 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 and Mild Cognitive Impairment, run by AbbVie at 9 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 4 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 9 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: Insufficient target engagement of ABT-957 (preclinical data)). 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?
Percentage of participants reporting treatment-emergent adverse events (time frame: For approximately 84 days). 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 NCT02573740, 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.