Alzheimer's DiseasePhase 2BEAT-ADNCT01782742

Bexarotene Amyloid Treatment for Alzheimer's Disease

A Phase 2 study testing Bexarotene in people with Alzheimer's Disease, run by The Cleveland Clinic at 1 site in United States.

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

Retinoid X receptors (RXR) are nuclear receptors that have been linked to numerous metabolic pathways relevant to Alzheimer's disease (AD) and Aβ (harmful protein) production and removal. The study drug "bexarotene" is an FDA approved anti-cancer agent but is not approved for use in Alzheimer's disease. Read more about this study

Who is it for?: Ages 50 to 90 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: Bexarotene
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Dec 2014
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 50 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females 50 to 90 of age inclusive.
Diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
Willing and able to provide informed consent by either the subject or subject's legal representative.
Willing and able to comply with study visits, treatment plan, laboratory tests, brain imaging and other procedures.
Subjects must have a positive 18f-AV-45 PET scan as determined by a qualified rater.
Mini-Mental State Examinations (MMSE) score between 10-20 inclusive.

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Must have a study partner who is able and willing to comply with all required study procedures.
Females must be postmenopausal.
Have at least eight years of education and should have previously (in pre-AD condition) been capable of reading, writing, and communicating effectively with others in English.
If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of these agents has been stable for at least 4 weeks prior to randomization
Normal laboratory findings at baseline including CBC, chemistry panel, serum lipids, liver functions, TSH, and vitamin B12.
Must consent to ApoE genotyping

Who cannot join

Any clinically relevant neurological disorder capable of producing a dementia syndrome including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies, frontotemporal dementia and others.
4 or more micro-hemorrhages (amyloid-related imaging abnormalities - hemorrhage type (ARIA-H) on baseline MRI or any evidence of amyloid-related imaging abnormalities - effusion type (ARIA-E) (Sperling et al, 2011).
History of malignancy within the past five years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer.
History of seizure in the past three years prior to randomization
Any contraindication of having brain MRI
Any contraindication of having PET (inability to lie flat and still for the duration of the scan, intolerance to previous PET such as hypersensitivity reaction to PET ligand or imaging agent)

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The subject has any unstable medical illness including hypertension, congestive heart failure, chronic obstructive pulmonary disease, renal failure, liver failure or other organ compromise.
Other clinically important abnormality on vital signs, physical examination, neurologic examination, laboratory results, or electrocardiogram (ECG) examination (e.g. Atrial fibrillation) that could compromise the study or be detrimental to the subject.
The subject has received bexarotene previously.
The subject has an allergy to bexarotene.
Has had a PET scan in the past 12 months.
Has had radiotherapy in the past year.
Have participated in an investigational drug or device study within 30 days prior to Visit 2.
Have been treated with immunomodulators to treat AD (vaccines, antibodies etc) within 6 months prior to visit 2
Unable to swallow uncrushed oral medication in capsule form
Have any condition or reason that, in the opinion of the investigator, which could interfere with the ability of the patients to participate or complete the trials, or places the patient at undue risk or complicates the interpretation of safety or efficacy data.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106

Other trials in United States

About this study

Official title: A Double Blind Placebo Controlled Randomized Study to Evaluate the Efficacy and Safety of Bexarotene in Patients With Mild to Moderate Alzheimer's Disease

This study aims to determine the safety and effect on abnormal proteins found in the brain (based on brain scans) of 300 mg of "bexarotene" administered for one month compared to placebo (inactive agent).

Conditions: Alzheimer's Disease
Being tested: Bexarotene, Placebo
Keywords: Mild to Moderate 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.

BexaroteneDrug
Also called Targretin
Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo
PlaceboDrug

Study groups in NCT01782742
Study group	Role	What they receive
Bexarotene treatment Arm	Active comparator	75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4. Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks) Receives: Drug: Bexarotene
Placebo	Placebo comparator	1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4. Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain
The primary study endpoint for all subjects is the change from baseline to Week 4 in amyloid burden as measured by standard uptake units regional (SUVr) on amyloid brain imaging obtained through 18F-AV-45 PET
Measured: Baseline to Week 4
Primary Outcome by Genotype (ALL SUBJECTS)
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers compared to E-4 non-carriers)
Measured: Baseline to Week 4
Primary Outcome by Genotype (NON ApoE4 CARRIERS)
Measures changes from baseline on treatment compared to placebo at week 4 on composite and regional Beta Amyloid burden according to ApoE genotype (NON ApoE4 CARRIERS)
Measured: Baseline to Week 4
Primary Outcome by Genotype (ApoE4 CARRIERS)
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers)
Measured: Baseline to Week 4
Primary Outcome by Genotype (HETEROZYGOTE ApoE4 CARRIERS)
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HETEROZYGOTE ApoE4 CARRIERS)
Measured: Baseline to Week 4
Primary Outcome by Genotype (HOMOZYGOTE ApoE4 CARRIERS)
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HOMOZYGOTE ApoE4 CARRIERS)
There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm.
Measured: Baseline to Week 4

Secondary outcomes (9)

Change in MMSE Score in ALL Subjects From Baseline to Week 4
The MMSE evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons. A lower score indicates more cognitive impairment. The lowest score that any particular person can get is 0 and the highest score is 30.
Measured: Baseline to Week 4
Change in ADAS-Cog Score in ALL Subjects From Baseline to Week 4
The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 85 (worse). A positive change indicates cognitive worsening.
Measured: Baseline to Week 4
Change in the Global Clinical Dementia Rating Score in ALL Subjects From Baseline to Week 4
The CDR is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe (CDR score of 0, 0.5, 1, 2, or 3, respectively). Higher score means more severe dementia rating. The score is based on interviews with the participant and study partner, using a structured interview that assesses six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
Measured: Baseline to Week 4
Change in NPI Scores in ALL Subjects From Baseline to Week 4
The NPI is a well validated, reliable, multi-item instrument to assess psychopathology in AD based on interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric disturbances. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously) as well as severity (1=mild, 2=moderate, 3=severe). The overall score and the score for each subscale are the product of severity and frequency. Overall score range from 0 meaning no disturbance to 144 meaning severe disturbance
Measured: Baseline to Week 4
Change in the Activities of Daily Living (ADCS-ADL) Score in ALL Subjects From Baseline to Week 4
The ADCS-ADL is an activities-of-daily-living inventory developed by the ADCS to assess functional performance in participants with AD (Galasko et al., 1997). Using a structured interview format, study partners are queried as to whether participants attempted each item in the inventory during the prior 4 weeks and their level of performance. Overall score range from 0 meaning fully independent to 78 meaning fully dependent on assistance for activities of daily living
Measured: Baseline to Week 4
Secondary Outcome Measuring Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (ALL SUBJECTS)
Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes
Measured: Baseline to Week 4
Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (Non ApoE4 Carriers)
Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes (non ApoE4 carriers)
Measured: Baseline to Week 4
Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in All Subjects
This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in all subjects
Measured: Baseline to Week 4
Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in Non ApoE4 Carriers
This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in non ApoE4 Carriers
Measured: Baseline to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Dec 2014

First posted4 Feb 2013 (estimated)
Study startFeb 2013
Primary completionAug 2014
Study completionDec 2014

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.
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 The Cleveland ClinicThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01782742
Sponsor's protocol ID: CCF-IRB 12-783
Acronym: BEAT-AD
Status last verified: Feb 2016
First submitted: 29 Jan 2013
Last updated: 12 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cummings JL, Zhong K, Kinney JW, Heaney C, Moll-Tudla J, Joshi A, Pontecorvo M, Devous M, Tang A, Bena J. Double-blind, placebo-controlled, proof-of-concept trial of bexarotene Xin moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Jan 29;8:4. doi: 10.1186/s13195-016-0173-2.
PubMed 26822146

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double Blind Placebo Controlled Randomized Study to Evaluate the Efficacy and Safety of Bexarotene in Patients With Mild to Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT01782742
Acronym / sponsor ID: BEAT-AD / CCF-IRB 12-783
Conditions: Alzheimer's Disease
Keywords: Mild to Moderate Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: Feb 2013
Primary completion: Aug 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 4 Feb 2013 (estimated)
Results: Posted 12 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Bexarotene treatment Arm	Active comparator	Drug: Bexarotene75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4. Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo	Placebo comparator	Drug: Placebo1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4. Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)

Who may qualify

Ages: 50 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Males or females 50 to 90 of age inclusive.
Diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
Willing and able to provide informed consent by either the subject or subject's legal representative.
Willing and able to comply with study visits, treatment plan, laboratory tests, brain imaging and other procedures.
Subjects must have a positive 18f-AV-45 PET scan as determined by a qualified rater.

Key exclusion criteria (16 listed)

Any clinically relevant neurological disorder capable of producing a dementia syndrome including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies, frontotemporal dementia and others.
4 or more micro-hemorrhages (amyloid-related imaging abnormalities - hemorrhage type (ARIA-H) on baseline MRI or any evidence of amyloid-related imaging abnormalities - effusion type (ARIA-E) (Sperling et al, 2011).
History of malignancy within the past five years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer.
History of seizure in the past three years prior to randomization
Any contraindication of having brain MRI

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
BexaroteneAlso: TargretinSubjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo	Drug	Bexarotene treatment Arm
Placebo	Drug	Placebo

Primary outcome

Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain
Time frame: Baseline to Week 4
The primary study endpoint for all subjects is the change from baseline to Week 4 in amyloid burden as measured by standard uptake units regional (SUVr) on amyloid brain imaging obtained through 18F-AV-45 PET
Primary Outcome by Genotype (ALL SUBJECTS)
Time frame: Baseline to Week 4
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers compared to E-4 non-carriers)
Primary Outcome by Genotype (NON ApoE4 CARRIERS)
Time frame: Baseline to Week 4
Measures changes from baseline on treatment compared to placebo at week 4 on composite and regional Beta Amyloid burden according to ApoE genotype (NON ApoE4 CARRIERS)
Primary Outcome by Genotype (ApoE4 CARRIERS)
Time frame: Baseline to Week 4
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers)
Primary Outcome by Genotype (HETEROZYGOTE ApoE4 CARRIERS)
Time frame: Baseline to Week 4
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HETEROZYGOTE ApoE4 CARRIERS)
Primary Outcome by Genotype (HOMOZYGOTE ApoE4 CARRIERS)
Time frame: Baseline to Week 4
This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HOMOZYGOTE ApoE4 CARRIERS) There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm.

9 secondary outcomes

Change in MMSE Score in ALL Subjects From Baseline to Week 4
Time frame: Baseline to Week 4
Change in ADAS-Cog Score in ALL Subjects From Baseline to Week 4
Time frame: Baseline to Week 4
Change in the Global Clinical Dementia Rating Score in ALL Subjects From Baseline to Week 4
Time frame: Baseline to Week 4
Change in NPI Scores in ALL Subjects From Baseline to Week 4
Time frame: Baseline to Week 4
Change in the Activities of Daily Living (ADCS-ADL) Score in ALL Subjects From Baseline to Week 4
Time frame: Baseline to Week 4
Secondary Outcome Measuring Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (ALL SUBJECTS)
Time frame: Baseline to Week 4
Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (Non ApoE4 Carriers)
Time frame: Baseline to Week 4
Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in All Subjects
Time frame: Baseline to Week 4
Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in Non ApoE4 Carriers
Time frame: Baseline to Week 4

Results and safety

Results posted to the registry on 12 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bexarotene Treatment Arm	16	15
Placebo	4	4

Primary outcome: Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain

Time frame: Baseline to Week 4. Mean (95% Confidence Interval). Unit: SUVr

Measure	Bexarotene n = 16	Placebo n = 4
Value	-0.03 (-0.06 to 0.01)	0.02 (-0.05 to 0.10)

Bexarotene vs Placebo: Mean Difference (Final Values): -0.05 (95% CI -0.13 to 0.03), p = 0.22, t-test, 2 sided

Primary outcome: Primary Outcome by Genotype (ALL SUBJECTS)

Time frame: Baseline to Week 4. Mean (95% Confidence Interval). Unit: SUVr

Measure	Bexarotene n = 16	Placebo n = 4
Frontal Medial Orbital	-0.043 (-0.081 to -0.006)	-0.021 (-0.096 to 0.054)
Anterior Cingulate	-0.040 (-0.080 to 0.000)	0.018 (-0.061 to 0.098)
Parietal	-0.003 (-0.034 to 0.027)	0.044 (-0.018 to 0.105)
Posterior Cingulate	-0.017 (-0.065 to 0.031)	0.044 (-0.052 to 0.141)
Precuneus	-0.027 (-0.069 to 0.014)	0.040 (-0.043 to 0.122)
Temporal	-0.038 (-0.075 to 0.000)	0.016 (-0.059 to 0.090)

Population analysed: Change om composite and regional Beta Amyloid burden according to ApoE genotype on ALL SUBJECTS

Primary outcome: Primary Outcome by Genotype (NON ApoE4 CARRIERS)

Time frame: Baseline to Week 4. Mean (95% Confidence Interval). Unit: SUVr

Measure	Bexarotene n = 4	Placebo n = 3
Composite	-0.097 (-0.155 to -0.040)	0.047 (-0.019 to 0.114)
Frontal Medial Orbital	-0.076 (-0.146 to -0.007)	0.005 (-0.075 to 0.085)
Anterior Cingulate	-0.096 (-0.166 to -0.026)	0.048 (-0.034 to 0.129)
Parietal	-0.068 (-0.107 to -0.029)	0.065 (0.020 to 0.110)
Posterior Cingulate	-0.113 (-0.180 to -0.046)	0.074 (-0.004 to 0.151)
Precuneus	-0.127 (-0.188 to -0.066)	0.062 (-0.008 to 0.132)
Temporal	-0.104 (-0.162 to -0.045)	0.031 (-0.037 to 0.098)

Population analysed: Change in composite and regional Beta Amyloid Burden on non-ApoE4 carriers

Primary outcome: Primary Outcome by Genotype (ApoE4 CARRIERS)

Time frame: Baseline to Week 4. Mean (95% Confidence Interval). Unit: SUVr

Measure	Bexarotene n = 12	Placebo n = 1
Composite	-0.005 (-0.041 to 0.031)	-0.048 (NA to NA)
Frontal Medial Orbital	-0.033 (-0.074 to 0.009)	-0.099 (NA to NA)
Anterior Cingulate	-0.022 (-0.062 to 0.019)	-0.069 (NA to NA)
Parietal	0.018 (-0.013 to 0.050)	-0.019 (NA to NA)
Posterior Cingulate	0.015 (-0.035 to 0.065)	-0.044 (NA to NA)
Precuneus	0.006 (-0.031 to 0.043)	-0.027 (NA to NA)
Temporal	-0.015 (-0.055 to 0.024)	-0.030 (NA to NA)

Population analysed: Change in composite and regional Beta Amyloid burden on ApoE4 carriers

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the time the participants signed the informed consent forms to the Post-Treatment Follow Up Visit approximating to 4 months of time when adverse events were captured. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bexarotene Treatment Arm	0 of 16 (0%)	14 of 16 (87.5%)	Not reported
Placebo	0 of 4 (0%)	0 of 4 (0%)	Not reported

Limitations and caveats (from the sponsor): Sample size of this trial is small. There was 1 participant withdrawal due to adverse event. Primary outcome measures were completed by all 20 participants as anticipated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26822146Cummings JL, Zhong K, Kinney JW, Heaney C, Moll-Tudla J, Joshi A, Pontecorvo M, Devous M, Tang A, Bena J. Double-blind, placebo-controlled, proof-of-concept trial of bexarotene Xin moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Jan 29;8:4. doi: 10.1186/s13195-016-0173-2.

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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.

Jeffrey L Cummings, MD, ScD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bexarotene in people with Alzheimer's Disease, run by The Cleveland Clinic 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 12 inclusion and 16 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 12 Feb 2016. 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. 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 12 Feb 2016). 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?

Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain (time frame: Baseline to Week 4). 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 NCT01782742, 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 12 Feb 2016.