Age-Related Memory DisordersPhase 2NCT00691808
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
A Phase 2 study testing LX6171 High Dose and LX6171 Low Dose in people with Age-Related Memory Disorders, run by Lexicon Pharmaceuticals at 2 sites in Netherlands.
Trial summary
The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Age-Related Memory Disorders
- What is being tested?
- LX6171 High Dose and LX6171 Low Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2008to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 60-80 years old.
- Complaints of memory loss in everyday life
- Non-smokers or very light smokers (no more than 10 cigarettes/day)
- Negative urine screen for drugs of abuse
- Ability to provide written informed consent
Who cannot join
- History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
- Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
- Clinically significant abnormality on electrocardiogram
- History of alcoholism or drug dependence
- Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Kendle Netherlands
Utrecht, 3584
Pharmaceutical Research Associates Group BV
Zuidlaren, 9470
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI)
The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).
- Conditions
- Age-Related Memory Disorders
- Being tested
- LX6171 High Dose, LX6171 Low Dose, Placebo
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX6171 High DoseDrug
A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
LX6171 Low DoseDrug
A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
PlaceboDrug
Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Experimental | Not described Receives: Drug: LX6171 High Dose |
| Low Dose | Experimental | Not described Receives: Drug: LX6171 Low Dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Were Exposed to LX6171
Measured: ≥28 days
Number of Participants Who Were Exposed to LX6171
Measured: 25 to 27 days
Number of Participants Who Were Exposed to LX6171
Measured: 14 to18 days
Number of Subjects Reporting at Least One Adverse Event (AE)
An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.
Measured: 28 days
Number of Subjects Reporting Adverse Events Leading to Withdrawal
Measured: 28 days
Treatment Compliance
Subjects were considered compliant if they had taken >70% of possible doses of the study drug.
Measured: End of study
Secondary outcomes (6)
Plasma Concentration
Measured: Day 28
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
The 15-Words Test is used to measure verbal learning and memory. Subjects are scored on the number of recognized words on a scale of 0-15, with 0 being the worst and 15 being the best. The baseline (Day -1) score was subtracted from the Day 28 score to obtain the Score Change from Baseline.
Measured: Day 28
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
Subjects are asked to recall words from the preceding week's 15-Words Test. Baseline (Day -1) scores (scale 0-15, 0 being the worst) were subtracted from Day 28 scores to obtain the score change from baseline.
Measured: Day 28
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
The subjects were asked to describe their memory ability in a variety of situations of everyday life (a list of 25 questions) using a 5-point scale, with a lower score being a negative assessment. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Measured: Day 28
Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
The Pittsburgh Sleep Quality Index is a self-rated questionnaire that assesses sleep quality and disturbances. Responses were scored on a scale of 0 to 3 where 3 is the negative extreme. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Measured: Day 28
Change From Baseline in Epworth Sleepiness Scale at Day 28
The Epworth Sleepiness Scale is a self-administered questionnaire used to help quantify a subject's level of daytime sleepiness. Subjects recorded their chances of dozing on a scale of 0 to 3, with 0 being no chance and 3 being a high chance. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-Related Memory DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip M. Brown, M.D., J.D., Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691808
- Sponsor's protocol ID
- LX6171.1-201-AAMI
- Other IDs
- LX6171.201
- Status last verified
- Feb 2010
- First submitted
- 2 Jun 2008
- Last updated
- 3 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI)
- ClinicalTrials.gov ID
- NCT00691808
- Acronym / sponsor ID
- LX6171.1-201-AAMI
- Conditions
- Age-Related Memory Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 3 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose | Experimental | Drug: LX6171 High Dose |
| Low Dose | Experimental | Drug: LX6171 Low Dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females aged 60-80 years old.
- Complaints of memory loss in everyday life
- Non-smokers or very light smokers (no more than 10 cigarettes/day)
- Negative urine screen for drugs of abuse
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
- Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
- Clinically significant abnormality on electrocardiogram
- History of alcoholism or drug dependence
- Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)
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 |
|---|---|---|
| LX6171 High DoseA high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. | Drug | High Dose |
| LX6171 Low DoseA low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. | Drug | Low Dose |
| PlaceboMatching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time. | Drug | Placebo |
Primary outcome
Number of Participants Who Were Exposed to LX6171
Time frame: ≥28 days
Number of Participants Who Were Exposed to LX6171
Time frame: 25 to 27 days
Number of Participants Who Were Exposed to LX6171
Time frame: 14 to18 days
Number of Subjects Reporting at Least One Adverse Event (AE)
Time frame: 28 days
An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.
Number of Subjects Reporting Adverse Events Leading to Withdrawal
Time frame: 28 days
Treatment Compliance
Time frame: End of study
Subjects were considered compliant if they had taken >70% of possible doses of the study drug.
6 secondary outcomes
Plasma Concentration
Time frame: Day 28
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
Time frame: Day 28
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
Time frame: Day 28
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
Time frame: Day 28
Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
Time frame: Day 28
Change From Baseline in Epworth Sleepiness Scale at Day 28
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Philip M. Brown, M.D., J.D. study director
Lexicon Pharmaceuticals, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LX6171 High Dose and LX6171 Low Dose in people with Age-Related Memory Disorders, run by Lexicon Pharmaceuticals at 2 sites in Netherlands.
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 5 inclusion and 5 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 3 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Who Were Exposed to LX6171 (time frame: ≥28 days). The study lists 6 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 3 Mar 2010.