Alzheimer's DiseasePhase 1NCT00867399
A Safety and Tolerability Study of ABT-126 in Elderly
A Phase 1 study testing ABT-126 in people with Alzheimer's Disease, run by Abbott at 1 site in United States.
Trial summary
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ABT-126
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2009
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy male or female subjects 65 years or greater.
- Has a MMSE score of 27 or higher.
Who cannot join
- History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
- History of any significant neurological disease.
- Has an estimated creatinine clearance < 30 mL/min
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 17283
Orlando, Florida, 32809
About this study
Official title: A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.
- Conditions
- Alzheimer's Disease
- Being tested
- ABT-126
- 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-126Drug
See arm for details
| Study group | Role | What they receive |
|---|---|---|
| 20mg of ABT-126 QD | Active comparator | 20 mg of ABT-126 QD for 10 days Receives: Drug: ABT-126 |
| 30mg and 45mg ABT-126 QD | Active comparator | 30 mg and 45mg of ABT-126 QD for 21 days Receives: Drug: ABT-126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Measured: Study Days -1 thru Day 28
Assess the Pharmacokinetics
Measured: Study Days -1 thru Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867399
- Sponsor's protocol ID
- M10-717
- Status last verified
- Sep 2010
- First submitted
- 19 Mar 2009
- Last updated
- 2 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects
- ClinicalTrials.gov ID
- NCT00867399
- Acronym / sponsor ID
- M10-717
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- First posted
- 23 Mar 2009 (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.
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20mg of ABT-126 QD | Active comparator | Drug: ABT-12620 mg of ABT-126 QD for 10 days |
| 30mg and 45mg ABT-126 QD | Active comparator | Drug: ABT-12630 mg and 45mg of ABT-126 QD for 21 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy male or female subjects 65 years or greater.
- Has a MMSE score of 27 or higher.
Key exclusion criteria (3 listed)
- History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
- History of any significant neurological disease.
- Has an estimated creatinine clearance < 30 mL/min
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-126See arm for details | Drug | 20mg of ABT-126 QD, 30mg and 45mg ABT-126 QD |
Primary outcome
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time frame: Study Days -1 thru Day 28
Assess the Pharmacokinetics
Time frame: Study Days -1 thru Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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-126 in people with Alzheimer's Disease, run by Abbott at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) (time frame: Study Days -1 thru Day 28). 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?
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 2 Nov 2010.