Alzheimer's DiseasePhase 1NCT01254448
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
A Phase 1 study testing TC-5619 in people with Alzheimer's Disease, run by Targacept Inc. at 10 sites in United States.
Trial summary
This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- TC-5619
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2010to May 2011
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal body mass index (BMI)
- Non-smoking for a minimum of 3 months
- Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG.
- Group 1 Only:
- Subjects a Mini Mental State Examination score between 12-22, inclusive.
- Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Subjects must have a reliable caregiver.
Who cannot join
- Subjects with clinically significant heart disease, pulmonary disease, diabetes, neurologic or psychiatric disease (Group 1 subjects must have Alzheimer's Disease), or any other illness that could interfere with interpretation of study results.
- Subjects with a past or current history of seizures cannot participate.
- Current use of donepezil, rivastigmine or galantamine.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Atlanta Center For Clinical Research
Atlanta, Georgia, 30308
Community Clinical Research
Austin, Texas, 78754
MD Clinical
Hallandale, Florida, 33009
Collaborative Neuroscience Network
Long Beach, California, 90806
Galiz Research
Miami Springs, Florida, 33166
Comprehensive Phase One
Miramar, Florida, 333025
Aspen Clinical Research
Orem, Utah, 84058
Compass Research, LLC
Orlando, Florida, 32806
Princeton Medical Institutes
Princeton, New Jersey, 08540
San Francisco Clinical Research Center
San Francisco, California, 94109
About this study
Official title: Two-Part, Sequential Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TC-5619-238 in Elderly Subjects With and Without Alzheimer's Disease
This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.
- Conditions
- Alzheimer's Disease
- Being tested
- TC-5619, Placebo
- 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.
TC-5619Drug
Group 1: 25 mg TC-5619 administered once daily for 28 days. Group 2: 50-150 mg TC-5619 administered once daily for 10 days.
PlaceboDrug
Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2). Receives: Drug: Placebo |
| TC-5619 | Experimental | Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2). Receives: Drug: TC-5619 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of participants with treatment-emergent adverse events
Measured: Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14
Secondary outcomes (3)
Pharmacokinetic profiles
Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 \& 2) and urine (Group 2) samples after multiple doses
Measured: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Markers of inflammation in cerebrospinal fluid
Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)
Measured: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Markers of inflammation in plasma
Dose related changes in markers of inflammation in plasma over time (Groups 1 \& 2)
Measured: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMay 2011
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targacept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Gerson, MD, Principal investigator, Comprehensive Phase One
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254448
- Sponsor's protocol ID
- TC-5619-238-CLP-003
- Status last verified
- Sep 2013
- First submitted
- 2 Dec 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Part, Sequential Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TC-5619-238 in Elderly Subjects With and Without Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01254448
- Acronym / sponsor ID
- TC-5619-238-CLP-003
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Targacept Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Dec 2010 (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 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2). |
| TC-5619 | Experimental | Drug: TC-5619Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2). |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal body mass index (BMI)
- Non-smoking for a minimum of 3 months
- Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG.
- Subjects a Mini Mental State Examination score between 12-22, inclusive.
- Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Key exclusion criteria (3 listed)
- Subjects with clinically significant heart disease, pulmonary disease, diabetes, neurologic or psychiatric disease (Group 1 subjects must have Alzheimer's Disease), or any other illness that could interfere with interpretation of study results.
- Subjects with a past or current history of seizures cannot participate.
- Current use of donepezil, rivastigmine or galantamine.
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 |
|---|---|---|
| TC-5619Group 1: 25 mg TC-5619 administered once daily for 28 days. Group 2: 50-150 mg TC-5619 administered once daily for 10 days. | Drug | TC-5619 |
| PlaceboGroup 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days. | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14
Number of participants with treatment-emergent adverse events
3 secondary outcomes
Pharmacokinetic profiles
Time frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Markers of inflammation in cerebrospinal fluid
Time frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Markers of inflammation in plasma
Time frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
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 4 Sep 2013.
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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.
George Gerson, MD principal investigator
Comprehensive Phase One
10 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 TC-5619 in people with Alzheimer's Disease, run by Targacept Inc. at 10 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 7 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 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14). 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 4 Sep 2013.