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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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

Other trials in Netherlands

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 groups in NCT00691808
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.

Feb 2008Oct 2008

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)

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

Results posted to the registry on 3 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose	35	35
Low Dose	36	35
Placebo	32	32

Primary outcome: Number of Participants Who Were Exposed to LX6171

Time frame: ≥28 days. Number. Unit: Participants

Measure	High Dose n = 35	Low Dose n = 36	Placebo n = 32
Value	35	33	31

Primary outcome: Number of Participants Who Were Exposed to LX6171

Time frame: 25 to 27 days. Number. Unit: Participants

Measure	High Dose n = 35	Low Dose n = 36	Placebo n = 32
Value	0	2	1

Primary outcome: Number of Participants Who Were Exposed to LX6171

Time frame: 14 to18 days. Number. Unit: Participants

Measure	High Dose n = 35	Low Dose n = 36	Placebo n = 32
Value	0	1	0

Primary outcome: Number of Subjects Reporting at Least One Adverse Event (AE)

Time frame: 28 days. Number. Unit: Participants

Measure	High Dose n = 35	Low Dose n = 36	Placebo n = 32
Value	25	22	26

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose	0 of 35 (0%)	25 of 35 (71.4%)	Not reported
Low Dose	0 of 36 (0%)	22 of 36 (61.1%)	Not reported
Placebo	0 of 32 (0%)	26 of 32 (81.3%)	Not reported

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.

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?

On the ClinicalTrials.gov record for NCT00691808.

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.