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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. Bexarotene acts as an RXR agonist that has reduced Aβ (harmful protein) in the brain in experimental models of 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bexarotene | Drug | Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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) | 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) | 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Cummings, MD, ScD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26822146 | Derived | 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. |
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49 participants were screened, 29 were screen failures, 20 participants were randomized to treatment. 1 was withdrawn after Week 4 treatment. Inclusion and exclusion criteria was the strict basis for eligibility.
Recruitment was conducted in the United States at one site. The first participant was enrolled in April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bexarotene Treatment Arm | 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) Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo |
| FG001 | Placebo | 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) Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Treatment Phase |
|
| ||||||||||||||||||
| Open Label Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bexarotene Treatment Arm | 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) Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age at Screening |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | SUVr | Baseline to Week 4 |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bexarotene Treatment Arm | 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) Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Cummings, MD, ScD | Cleveland Clinic Lou Ruvo Center for Brain Health | 702.483.6029 | cumminj@ccf.org |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug |
|
| 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. | 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. | 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 | 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 | 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 | 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) | 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 | 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 | Baseline to Week 4 |
| NOT COMPLETED |
|
| Placebo |
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) Placebo |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Years of Cognitive Symptoms | Mean | Standard Deviation | years |
|
| MMSE total score | 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. | Mean | Full Range | units on a scale |
|
| ADAS-Cog score | 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. | Mean | Full Range | units on a scale |
|
| CDR score | 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. | Mean | Full Range | units on a scale |
|
| NPI score | 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. | Mean | Full Range | units on a scale |
|
| NPI Distress Score | NPI distress score measures the distress that the caregiver experiences during the previous 4 weeks from the assessment date. Distress score is measured on a scale between 0 to 5. 0 being not at all distressed to 5 very severely or extremely distressed. The scores for all 12 domains are added up becomes the total score. 0 means no caregiver distress and 60 means extreme caregiver distress. | Mean | Full Range | units on a scale |
|
| ADCS-ADL score | 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. | Mean | Full Range | units on a scale |
|
| ApoE4 Status | Number | participants |
|
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|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | points | Baseline to Week 4 |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | points | Baseline to Week 4 |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Week 4 |
|
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | points | Baseline to Week 4 |
|
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|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | points | Baseline to Week 4 |
|
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|
| Primary | 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) | Change om composite and regional Beta Amyloid burden according to ApoE genotype on ALL SUBJECTS | Posted | Mean | 95% Confidence Interval | SUVr | Baseline to Week 4 |
|
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| Primary | 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) | Change in composite and regional Beta Amyloid Burden on non-ApoE4 carriers | Posted | Mean | 95% Confidence Interval | SUVr | Baseline to Week 4 |
|
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| Primary | 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) | Change in composite and regional Beta Amyloid burden on ApoE4 carriers | Posted | Mean | 95% Confidence Interval | SUVr | Baseline to Week 4 |
|
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| Primary | 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) | Change in composite and regional Beta Amyloid burden on Heterozygote ApoE4 carriers | Posted | Mean | 95% Confidence Interval | SUVr | Baseline to Week 4 |
|
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| Primary | 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. | Change in composite and regional Beta Amyloid burden on Homozygote ApoE4 carriers. There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm. | Posted | Mean | 95% Confidence Interval | SUVr | Baseline to Week 4 |
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| Secondary | 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 | Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes in ALL SUBJECTS. There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful. | Posted | Mean | 95% Confidence Interval | pmol/L | Baseline to Week 4 |
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| Secondary | 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) | Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels in non ApoE4 carriers. Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful. | Posted | Mean | 95% Confidence Interval | pmol/L | Baseline to Week 4 |
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| Secondary | 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 | There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful. | Posted | Mean | 95% Confidence Interval | ratio | Baseline to Week 4 |
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| Secondary | 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 | Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful. | Posted | Mean | 95% Confidence Interval | ratio | Baseline to Week 4 |
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| 0 |
| 16 |
| 14 |
| 16 |
| EG001 | Placebo | 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) Placebo | 0 | 4 | 0 | 4 |
| Blister on toe | Skin and subcutaneous tissue disorders | Systematic Assessment | Participant had a blister on 2nd toe of left foot |
|
| Elevated triglyceride levels | Hepatobiliary disorders | Systematic Assessment |
|
| Elevated cholesterol level | Gastrointestinal disorders | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Parietal |
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| Posterior Cingulate |
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| Precuneus |
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| Temporal |
|
| Anterior Cingulate |
|
| Parietal |
|
| Posterior Cingulate |
|
| Precuneus |
|
| Temporal |
|
| Anterior Cingulate |
|
| Parietal |
|
| Posterior Cingulate |
|
| Precuneus |
|
| Temporal |
|
| Anterior Cingulate |
|
| Parietal |
|
| Posterior Cingulate |
|
| Precuneus |
|
| Temporal |
|
| Title | Measurements |
|---|---|
|
| Parietal |
|
| Posterior Cingulate |
|
| Precuneus |
|
| Temporal |
|