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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG049752 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study is intended to investigate the safety of candesartan, a blood pressure medication, in non-hypertensive individuals who have mild cognitive impairment (MCI) due to Alzheimer's disease and its effect on disease biomarkers.
This is a double-blind placebo-control randomized clinical trial that compares candesartan to placebo in individuals with mild cognitive impairment (MCI) who also have positive Alzheimer's Disease (AD) biomarkers. The investigators will assess if blocking the effect of Ang II using angiotensin receptor blockers (ARBs) is safe in non hypertensive MCI individuals and whether the use of candesartan will be associated with changes in cerebrospinal fluid disease biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan | Experimental | Candesartan will be given orally once a day in a stepwise manner as follows: All participants will be initiated on 8 mg candesartan. The dose will be increased in 2 week increments to 16 mg and 32 mg as long as the systolic blood pressure (SBP) >100 mm Hg, diastolic blood pressure (DBP) >40 mm Hg and participant reports no symptoms of hypotension (dizziness or weakness). The highest achievable dose will be the Maximal Tolerated Dose (MTD) and the participant will receive this dose for the remaining duration of the study (participants will be treated for 1 year). |
|
| Placebo | Placebo Comparator | Participants will receive a matched placebo once a day orally for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | A matched placebo will be given once daily for 12 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Hypotensive Episode | Hypotension is defined as blood pressure <100/40 mm Hg. Blood pressure was measured according to the American Heart Association guidelines with the subject in the sitting position and rested for 5 minutes. An appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference) was used and correct cuff placement (1-2 inches above the brachial pulse on bare arm) was ensured. | Up to Month 12 |
| Number of Participants With Symptoms of Hypotension | Participants were asked to report any symptoms of hypotension (dizziness, weakness, fatigue and lightheadedness). All participants were given a telephone number to reach physician 24-hours per day to report symptoms they experience. The number of participants reporting symptoms of hypotension is reported here. | Up to Month 12 |
| Number of Participants With Hypotensive Episodes and Symptoms | The number of participants with reported episodes hypotension as well as symptoms of hypotension. | Up to Month 12 |
| Number of Participants With Elevated Serum Creatinine | The levels of creatinine were obtained from blood samples. Elevated serum creatinine is defined as levels >2.5 milligram per deciliter (mg/dL). Elevated serum creatinine is indicative of decreased renal function. | Up to Month 12 |
| Number of Participants With Hyperkalemia | The levels of potassium were obtained from blood samples. Hyperkalemia is defined as potassium levels >5.9 milliequivalent per deciliter (meq/dL). Hyperkalemia is an indication of kidney dysfunction. | Up to Month 12 |
| Number of Participants Discontinuing Study Medication |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal Fluid (CSF) Total Tau Levels | CSF total tau (t-tau) levels were analyzed from CSF samples obtained via lumbar puncture. Normal values for t-tau are < 450 pg/ml. Elevated levels of t-tau indicate worsening disease. | Baseline, Month 12 |
| Cerebrospinal Fluid (CSF) of Tau Phosphorylated at Threonine 181 (p-tau181) Levels |
Not provided
Inclusion Criteria:
Mild Cognitive Impairment, defined by:
Amyloid positivity determined by measuring the amyloid content in the brain. This can be determined by either cerebrospinal fluid (CSF) amyloid level or an amyloid scan (PIB-PET)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ihab Hajjar, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Wesley Woods Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36440097 | Derived | Hajjar I, Okafor M, Wan L, Yang Z, Nye JA, Bohsali A, Shaw LM, Levey AI, Lah JJ, Calhoun VD, Moore RH, Goldstein FC. Safety and biomarker effects of candesartan in non-hypertensive adults with prodromal Alzheimer's disease. Brain Commun. 2022 Oct 25;4(6):fcac270. doi: 10.1093/braincomms/fcac270. eCollection 2022. |
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Participants were recruited from the Wesley Woods Health Center of Emory Healthcare in Atlanta, Georgia, USA. Participant enrollment began June 30, 2016 and all follow up was complete by August 17, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan | Participants receiving candesartan given orally once a day in a stepwise manner. Participants were initiated on 8 mg candesartan. The dose was increased in 2 week increments to 16 mg and 32 mg, as tolerated. The highest achievable dose was the Maximal Tolerated Dose (MTD) and the participant received this dose for the remaining duration of the study (12 months total). |
| FG001 | Placebo | Participants receiving a placebo to match candesartan once a day orally for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Candesartan | Participants receiving candesartan given orally once a day in a stepwise manner. Participants were initiated on 8 mg candesartan. The dose was increased in 2 week increments to 16 mg and 32 mg, as tolerated. The highest achievable dose was the Maximal Tolerated Dose (MTD) and the participant received this dose for the remaining duration of the study (12 months total). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With a Hypotensive Episode | Hypotension is defined as blood pressure <100/40 mm Hg. Blood pressure was measured according to the American Heart Association guidelines with the subject in the sitting position and rested for 5 minutes. An appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference) was used and correct cuff placement (1-2 inches above the brachial pulse on bare arm) was ensured. | Posted | Count of Participants | Participants | Up to Month 12 |
|
Information on adverse events was collected for the duration of each participant's study enrollment, from the time that individuals gave consent to participate through their final study visit (up to 12 months).
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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 | Candesartan | Participants receiving candesartan given orally once a day in a stepwise manner. Participants were initiated on 8 mg candesartan. The dose was increased in 2 week increments to 16 mg and 32 mg, as tolerated. The highest achievable dose was the Maximal Tolerated Dose (MTD) and the participant received this dose for the remaining duration of the study (12 months total). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ihab Hajjar, MD | University of Texas Southwestern | 214-645-9533 | ihabhajjar@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2020 | Aug 25, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2019 | Sep 20, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| C081643 | candesartan |
| C077793 | candesartan cilexetil |
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| Candesartan |
| Drug |
Candesartan will be started at 8 mg orally, once daily. The dose will be increased in 2 week increments to 16 mg and 32 mg orally, once a day, as long as SBP>100 mm Hg, DBP>40 mm Hg and there are no reported symptoms of hypotension (dizziness or weakness). Candesartan will be given for a total of 12 months. |
|
|
The number of participants who discontinued the study medication is presented here. |
| Up to Month 12 |
CSF levels of p-tau181 were analyzed from CSF samples obtained via lumbar puncture. P-tau181 is a biomarker that is elevated in persons with Alzheimer's disease. Higher values indicate worsening disease. |
| Baseline, Month 12 |
| Cerebrospinal Fluid (CSF) Amyloid Aβ42 Levels | CSF Aβ42 levels were analyzed from CSF samples obtained via lumbar puncture. Aβ42 is a biomarker for Alzheimer's disease and lower values indicate worsening disease and an increased accumulation of amyloid in the brain. | Baseline, Month 12 |
| Cerebrospinal Fluid (CSF) Amyloid Aβ40 Levels | CSF Aβ40 levels were analyzed from CSF samples obtained via lumbar puncture. Lower values indicate worsening disease and an increased brain accumulation of amyloid. | Baseline, Month 12 |
| Cerebrospinal Fluid (CSF) Amyloid Aβ42/Aβ40 Levels | CSF Aβ42/Aβ40 levels were analyzed from CSF samples obtained via lumbar puncture. A lower ratio indicates worsening disease. | Baseline, Month 12 |
| Pulse Wave Velocity (PWV) | Arterial stiffness was assessed by Pulse Wave Velocity (PWV). PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s). Lower values indicate a preferable measurement of arterial stiffness. | Baseline, Month 12 |
| Augmentation Index (AI) | Arterial stiffness was assessed by Augmentation Index (AI). The AI is a ratio measure of augmentation of central arterial pressure reflected in a pulse wave; the value is multiplied by 100 to provide a percentage. AI increases with age and is higher in persons with cardiovascular disease states. A lower value indicates a preferable state of arterial stiffness. | Baseline, Month 12 |
| Hippocampal Volume | Structural MRI images were acquired in order to assess hippocampal volume. Decreased hippocampal volume suggests neurodegenerative changes | Baseline, Month 12 |
| Vasoreactivity | Cerebrovascular reactivity (CVR) is assessed with blood oxygenation level-dependent (BOLD) MRI. Vasoreactivity (VR) is the degree of change in BOLD signal relative to change in end tidal CO2. CVR is an indicator of microvascular function (higher indicates better function) | Month 12 |
| Global Standardized Uptake Value Ratio (SUVR) of (11)C-Pittsburgh Compound B ((11)C-PiB) | In-vivo amyloid imaging with positron emission tomography (PET) was conducted after intravenous administration of 15±1.5 millicurie (mCi) of the radiotracer (11)C-PiB. SUVR is a ratio of PET uptake measured in the brain region of interest and a disease free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease. | Baseline, 12 Months |
| Global Standardized Uptake Value Ratio (SUVR) of [18F]T807 | In-vivo tau-PET imaging was conducted using the radiotracer [18F]T807. SUVR is a ratio of PET uptake measured in the brain region of interest and a disease free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease. | Baseline, 12 Months |
| Clinical Dementia Rating (CDR) Score | The CDR rates each of the six general domains involving memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. An overall score, ranging from 0 to 3, can be calculated. A score of 0 = normal, 0.5 = very mild dementia, 1 = mild dementia, 2 = moderate dementia, and 3 = severe dementia. | Baseline, Month 12 |
| EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) Toolbox Composite Score | The EXAMINER toolbox battery includes 11 tasks that generate 15 primary variables. Within this set, the EXAMINER includes working memory, inhibition, set shifting, and fluency. The parts of EXAMINER that were used for this study include: Flanker task (inhibition) which involves responding to a central stimulus while ignoring flanking stimuli that are either compatible or incompatible with the central stimulus; Set-shifting, a measure of mental flexibility; Spatial 1-Back test assesses spatial working memory; Dot Counting test assesses verbal working memory; Verbal Fluency tested using a List Generation test which require the participant to generate words beginning with a specific letter, and category fluency in which the participant generates words from a specified category (e.g., animals, fruits). A composite score is calculated where scores range from -1 to +1 and higher are reflective of better executive function. | Baseline, Month 6, Month 12 |
| Hopkins Verbal Learning Test (HVLT) Delayed Recall Score | The Hopkins Verbal Learning Test (HVLT) is used to assess memory domains. Participants are read a list of 12 words and are asked to recall as many as they can remember. This is repeated for 3 trials followed by a 20 minute delay, and then participants are asked to recall as many words as they can. The delayed recall score ranges from 0 to 12 and higher scores indicate better memory. | Baseline, Month 6, Month 12 |
| Trail Making Test (TMT) Part B | The Trail Making Test assesses executive function. In Part B of the TMT participants connect circles labeled with letters and numbers, in ascending order. The score is the amount of time it takes for the participant to complete the task. The average time is 75 seconds and times greater than 273 seconds indicate a deficit with executive function. | Baseline, Month 6, Month 12 |
| Trail Making Test (TMT) Part B - A | In Parts A and B of the TMT, participants connect circles labeled with numbers, in ascending order. The score is the amount of time (in seconds) it takes for the participant to complete the task. The TMT Part A score reflects visuoperceptual abilities, and subtracting the score for Part A from the score from Part B (Part B-A, in seconds) provides a more accurate assessment of executive function. A lower score indicates greater executive function. | Baseline, Month 6, Month 12 |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| BG001 | Placebo | Participants receiving a placebo to match candesartan once a day orally for 12 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Sitting Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Sitting Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Sitting Heart Rate | Mean | Standard Deviation | beats per minute |
|
| Montreal Cognitive Assessment (MoCA) Score | MoCA is an instrument to screen for mild cognitive dysfunction, assessing the cognitive domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total scores range from 0 to 30 with higher scores indicating better cognitive function. A normal score is considered to be 26 or higher. | Mean | Standard Deviation | score on a scale |
|
| Number of Participants Taking Cholinesterase inhibitors or Memantine | Count of Participants | Participants |
|
| OG001 | Placebo | Participants receiving a placebo to match candesartan once a day orally for 12 months. |
|
|
| Primary | Number of Participants With Symptoms of Hypotension | Participants were asked to report any symptoms of hypotension (dizziness, weakness, fatigue and lightheadedness). All participants were given a telephone number to reach physician 24-hours per day to report symptoms they experience. The number of participants reporting symptoms of hypotension is reported here. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Primary | Number of Participants With Hypotensive Episodes and Symptoms | The number of participants with reported episodes hypotension as well as symptoms of hypotension. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Primary | Number of Participants With Elevated Serum Creatinine | The levels of creatinine were obtained from blood samples. Elevated serum creatinine is defined as levels >2.5 milligram per deciliter (mg/dL). Elevated serum creatinine is indicative of decreased renal function. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Primary | Number of Participants With Hyperkalemia | The levels of potassium were obtained from blood samples. Hyperkalemia is defined as potassium levels >5.9 milliequivalent per deciliter (meq/dL). Hyperkalemia is an indication of kidney dysfunction. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Primary | Number of Participants Discontinuing Study Medication | The number of participants who discontinued the study medication is presented here. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Secondary | Cerebrospinal Fluid (CSF) Total Tau Levels | CSF total tau (t-tau) levels were analyzed from CSF samples obtained via lumbar puncture. Normal values for t-tau are < 450 pg/ml. Elevated levels of t-tau indicate worsening disease. | This analysis includes participants who had CSF samples collected. | Posted | Least Squares Mean | Standard Error | Picograms per milliliter (pg/ml) | Baseline, Month 12 |
|
|
|
| Secondary | Cerebrospinal Fluid (CSF) of Tau Phosphorylated at Threonine 181 (p-tau181) Levels | CSF levels of p-tau181 were analyzed from CSF samples obtained via lumbar puncture. P-tau181 is a biomarker that is elevated in persons with Alzheimer's disease. Higher values indicate worsening disease. | This analysis includes participants who had CSF samples collected. | Posted | Least Squares Mean | Standard Error | pg/ml | Baseline, Month 12 |
|
|
|
| Secondary | Cerebrospinal Fluid (CSF) Amyloid Aβ42 Levels | CSF Aβ42 levels were analyzed from CSF samples obtained via lumbar puncture. Aβ42 is a biomarker for Alzheimer's disease and lower values indicate worsening disease and an increased accumulation of amyloid in the brain. | This analysis includes participants who had CSF samples collected. | Posted | Least Squares Mean | Standard Error | pg/ml | Baseline, Month 12 |
|
|
|
| Secondary | Cerebrospinal Fluid (CSF) Amyloid Aβ40 Levels | CSF Aβ40 levels were analyzed from CSF samples obtained via lumbar puncture. Lower values indicate worsening disease and an increased brain accumulation of amyloid. | This analysis includes participants who had CSF samples collected. | Posted | Least Squares Mean | Standard Error | pg/ml | Baseline, Month 12 |
|
|
|
| Secondary | Cerebrospinal Fluid (CSF) Amyloid Aβ42/Aβ40 Levels | CSF Aβ42/Aβ40 levels were analyzed from CSF samples obtained via lumbar puncture. A lower ratio indicates worsening disease. | This analysis includes participants who had CSF samples collected. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline, Month 12 |
|
|
|
| Secondary | Pulse Wave Velocity (PWV) | Arterial stiffness was assessed by Pulse Wave Velocity (PWV). PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s). Lower values indicate a preferable measurement of arterial stiffness. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Baseline, Month 12 |
|
|
|
| Secondary | Augmentation Index (AI) | Arterial stiffness was assessed by Augmentation Index (AI). The AI is a ratio measure of augmentation of central arterial pressure reflected in a pulse wave; the value is multiplied by 100 to provide a percentage. AI increases with age and is higher in persons with cardiovascular disease states. A lower value indicates a preferable state of arterial stiffness. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of arterial stiffness | Baseline, Month 12 |
|
|
|
| Secondary | Hippocampal Volume | Structural MRI images were acquired in order to assess hippocampal volume. Decreased hippocampal volume suggests neurodegenerative changes | Posted | Mean | Standard Error | mm^3 | Baseline, Month 12 |
|
|
|
| Secondary | Vasoreactivity | Cerebrovascular reactivity (CVR) is assessed with blood oxygenation level-dependent (BOLD) MRI. Vasoreactivity (VR) is the degree of change in BOLD signal relative to change in end tidal CO2. CVR is an indicator of microvascular function (higher indicates better function) | Posted | Least Squares Mean | 95% Confidence Interval | (ml/100g/min)/mmHg | Month 12 |
|
|
|
| Secondary | Global Standardized Uptake Value Ratio (SUVR) of (11)C-Pittsburgh Compound B ((11)C-PiB) | In-vivo amyloid imaging with positron emission tomography (PET) was conducted after intravenous administration of 15±1.5 millicurie (mCi) of the radiotracer (11)C-PiB. SUVR is a ratio of PET uptake measured in the brain region of interest and a disease free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease. | Posted | Mean | 95% Confidence Interval | Ratio of target and reference regions | Baseline, 12 Months |
|
|
|
| Secondary | Global Standardized Uptake Value Ratio (SUVR) of [18F]T807 | In-vivo tau-PET imaging was conducted using the radiotracer [18F]T807. SUVR is a ratio of PET uptake measured in the brain region of interest and a disease free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease. | Posted | Mean | Standard Error | Ratio of target and reference regions | Baseline, 12 Months |
|
|
|
| Secondary | Clinical Dementia Rating (CDR) Score | The CDR rates each of the six general domains involving memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. An overall score, ranging from 0 to 3, can be calculated. A score of 0 = normal, 0.5 = very mild dementia, 1 = mild dementia, 2 = moderate dementia, and 3 = severe dementia. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 12 |
|
|
|
| Secondary | EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) Toolbox Composite Score | The EXAMINER toolbox battery includes 11 tasks that generate 15 primary variables. Within this set, the EXAMINER includes working memory, inhibition, set shifting, and fluency. The parts of EXAMINER that were used for this study include: Flanker task (inhibition) which involves responding to a central stimulus while ignoring flanking stimuli that are either compatible or incompatible with the central stimulus; Set-shifting, a measure of mental flexibility; Spatial 1-Back test assesses spatial working memory; Dot Counting test assesses verbal working memory; Verbal Fluency tested using a List Generation test which require the participant to generate words beginning with a specific letter, and category fluency in which the participant generates words from a specified category (e.g., animals, fruits). A composite score is calculated where scores range from -1 to +1 and higher are reflective of better executive function. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 6, Month 12 |
|
|
|
| Secondary | Hopkins Verbal Learning Test (HVLT) Delayed Recall Score | The Hopkins Verbal Learning Test (HVLT) is used to assess memory domains. Participants are read a list of 12 words and are asked to recall as many as they can remember. This is repeated for 3 trials followed by a 20 minute delay, and then participants are asked to recall as many words as they can. The delayed recall score ranges from 0 to 12 and higher scores indicate better memory. | Posted | Least Squares Mean | Standard Error | number of words recalled | Baseline, Month 6, Month 12 |
|
|
|
| Secondary | Trail Making Test (TMT) Part B | The Trail Making Test assesses executive function. In Part B of the TMT participants connect circles labeled with letters and numbers, in ascending order. The score is the amount of time it takes for the participant to complete the task. The average time is 75 seconds and times greater than 273 seconds indicate a deficit with executive function. | Posted | Least Squares Mean | Standard Error | seconds | Baseline, Month 6, Month 12 |
|
|
|
| Secondary | Trail Making Test (TMT) Part B - A | In Parts A and B of the TMT, participants connect circles labeled with numbers, in ascending order. The score is the amount of time (in seconds) it takes for the participant to complete the task. The TMT Part A score reflects visuoperceptual abilities, and subtracting the score for Part A from the score from Part B (Part B-A, in seconds) provides a more accurate assessment of executive function. A lower score indicates greater executive function. | Posted | Least Squares Mean | Standard Error | seconds | Baseline, Month 6, Month 12 |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 20 |
| 38 |
| EG001 | Placebo | Participants receiving a placebo to match candesartan once a day orally for 12 months. | 0 | 39 | 0 | 39 | 17 | 39 |
| Fatigue, tiredness, weakness | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lightheadedness | General disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pain at back of head | General disorders | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
|
| Vasovagal syncope | General disorders | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Runny nose | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Month 12 |
|
| Month 12 |
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| Month 12 |
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| Month 12 |
|