Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease, Dementia
Brief summary
Cognitive aging is a major source of disability in an increasingly aging population. The paucity of effective treatments for cognitive aging disorders, and most importantly in Alzheimer's disease instigates a need for further research into novel therapeutic possibilities. Alzheimer's disease is the most common neurodegenerative disorder and its prevalence steeply increases. Glutamate-mediated excitotoxicity in neuropsychiatric disorders and in particular in Alzheimer's disease has been shown to cause significant cerebral damage. Early effective therapeutic intervention in Alzheimer's disease is critical in order to prevent or at least slow down neuropathological progression that will lead to widespread irreversible neuronal loss and significant cognitive dysfunction. Riluzole, a glutamate modulator agent, will be tested in mild Alzheimer's disease patients. Cognitive functional changes along with two established in vivo biomarkers, namely, Magnetic Resonance Spectroscopy (MRS) and Fluorodeoxyglucose (18F) positron emission tomography (FDG-PET) will be evaluated.
Detailed description
A double-blinded, randomized, placebo-controlled study will be performed. Forty-two individuals with a diagnosis of mild Alzheimer's disease between 50-95 years old will complete the study. All forty-two individuals will have been on an acetylcholinesterase inhibitor, which is FDA approved for the treatment of Alzheimer's disease, for at least 2 months prior to initiating the study, unless the medication was not previously tolerated. Twenty to twenty-two mild Alzheimer's disease patients will receive riluzole and another 20-22 will receive a placebo. All patients will have a neurological evaluation and neuropsychological tests performed to confirm that they meet criteria for probable Alzheimer's disease set out by the National Institute on Aging - Alzheimer's disease Association that recently revisited the NINCDS-ADRDA criteria along with FDG-PET biomarker consistent with Alzheimer's disease.
Interventions
DRUGRiluzole
20-22 subjects between the ages of 60-85 will receive study drug.
DRUGPlacebo
20-22 subjects between the ages of 60-85 will receive placebo
Sponsors
Rockefeller University
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Male or female; 50 - 95 years old with mild Alzheimer's disease determined after neurological and neuropsychological evaluation following the National Institute on Aging - Alzheimer's disease Association criteria that recently revisited the NINCDS-ADRDA criteria. For mild Alzheimer's disease, Clinical Dementia Ratings Scale (CDR) should be 0.5 or 1 and Mini Mental State Examination (MMSS) between 19 and 27. * Must be on donepezil (Aricept®) or rivastigmine (Exelon®) or galantamine (Razadyne®) at a consistent dose for at least 2 months. Patients will be considered for inclusion if they were previously unable to tolerate acetylcholinesterase inhibitors and as a result, are no longer on the medication for at least 2 months. * Must be fluent in English * The subject will appoint or have previously appointed a health care proxy specifically designated for research consent and that this be documented.
Exclusion criteria
* Severe Alzheimer's disease and other dementias as determined by neuropsychological testing and neurological evaluation. * Previous riluzole treatment. * MRI contraindication (severe claustrophobia, metal implants, shunts, pacemaker, joint implants, metal valves). * Currently taking medications that either have evidence of glutamatergic activity or has previous MRS evidence of effects on brain glutamate levels at the discretion of the PI such as memantine, lamotrigine, lithium, opiates, bupropion, psychostimulants such as amphetamines and methylphenidate, tricyclic antidepressants, benzodiazepines and any other drug that the investigators judge might interfere with the study. (subjects on those medications may still be included in the study however only the values of NAA from MRS will be utilized and not the glutamate measurements). * Currently a user of the following illicit drugs: cocaine, methylenedioxymethamphetamine (MDMA) (ecstasy), heroin and other opioids or has a history of drug or alcohol abuse within the past 5 years. * Serum creatinine \>1.5 times the upper limit of normal. * Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or bilirubin \>1.5 times the upper limit of normal. * History of brain disease including Parkinson's Disease, severe brain trauma, seizures, history of stroke, clinically significant lacunar infarct in a region important for cognition or multiple lacunes or a cortical infarct or focal lesions of clinical significance, multiple sclerosis, mental retardation, normal pressure hydrocephalus, central nervous system (CNS) tumor, Huntington's disease, subdural hematoma or other serious neurological disorder. * Uncontrolled diabetes mellitus (Hba1c higher than 7) or chronically uncontrolled hypertension. * Subject must not be taking Namenda® (memantine) for 6-weeks prior to study entrance. * Currently taking any concomitant hepatotoxic drugs such as allopurinol, methyldopa and sulfasalazine. * Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary artery disease requiring coronary bypass surgery, unstable angina, clinically evident congestive heart failure within 6 months prior to the screening visit. * Current smoker or user of nicotine-containing products, such as chewing tobacco, nicotine patch or gum for the past 2 months. * Current untreated major depression defined by Geriatric Depression Scale \> 20. * Participation in any investigational or marketed drug or device trial within 30 days prior to the screening visit. * Significant neuropsychiatric illnesses such as bipolar disorder, schizophrenia, moderate-severe anxiety, vascular dementia, Creutzfeldt-Jakob dementia, HIV dementia, and dementia in other specified diseases. * Subjects who have been on donepezil for longer than 5 years. * Weight\> 300 pounds. * Lactose intolerance. * Any medical or social condition that, in the opinion of the Investigator, might pose additional risk to the participant or confound the results of the study. * Positive Hepatitis Serology (Hep. B antigen+ or Hep. C antibody+)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Change from baseline to 6 months | Change from baseline to 6 months in cerebral glucose metabolism measured with FDG PET in posterior cingulate cortex, hippocampus, precuneus, and medial temporal, lateral temporal, inferior parietal, and frontal lobes, referred to collectively as our pre-specified regions of interest. Fluorodeoxyglucose (FDG)-positron emission tomography (PET) is an imaging procedure that measures glucose metabolism in the brain.It is a well-established Alzheimer's disease biomarker and predictor of disease progression. For each FDG PET scan, 5 mCi of fluorodeoxyglucose was administered followed by a 40 minute uptake period during which the participant was in a resting state. Images were acquired on a Siemens Biograph 64mCT scanner as a series of 4 frames of 5 minutes each. Using SPM12 (Wellcome Trust), motion correction was performed and frames averaged into a static image. Each 6 month scan was coregistered to the baseline FDG scan, which was co-registered to the participant's T1-weighted MRI scan. |
| Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | Changes from baseline to 6 months | N-acetylaspartate (NAA) is a neuronal viability marker measured through magnetic resonance spectroscopy (1H MRS).In vivo brain levels of NAA, glutamate, tCr and other major metabolites were obtained using 1H MRS and a 2x2x2-cm3 Posterior Cingulate Cortex (PC) voxel of interest in approximately 6.5 minutes using the constant-time point-resolved spectroscopy (CT-PRESS) technique with TE 30 ms, 129 constant-time increments (t1) of 0.8ms, and TR 1500 ms and a receive-only 8-channel phased-array head coil.The levels of NAA and other metabolites were expressed semi-quantitatively as ratios of peak areas relative to that of the unsuppressed water signal (W) from the same voxels. For consistency with earlier MRS literature, levels of the same metabolites were also expressed as peak ratios relative to tCr area in the same voxel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glutamate Levels Measured Through 1H MRS | Change from baseline to 6 months | In vivo measurement of glutamate with 1H magnetic resonance spectroscopy (MRS) (a neuroimaging study) in posterior cingulate as a marker of target engagement at three and six months compared to baseline.In vivo brain levels of glutamate, tCr and other major metabolites were obtained using 1H MRS and a 2x2x2-cm3 Posterior Cingulate Cortex voxel of interest in approximately 6.5 minutes using the constant-time point-resolved spectroscopy (CT-PRESS) technique with TE 30 ms, 129 constant-time increments (t1) of 0.8ms, and TR 1500 ms and a receive-only 8-channel phased-array head coil.The levels of glutamate and other metabolites were expressed semi-quantitatively as ratios of peak areas relative to that of the unsuppressed water signal (W) from the same voxels. For consistency with earlier MRS literature, levels of the same metabolites were also expressed as peak ratios relative to tCr area in the same voxel. |
| Alzheimer's Disease Assessment Scale (ADAS) - Cognitive Subscale (ADAScog) | baseline to 6 months | The ADAS comprises two subscales, cognitive and non-cognitive. The Cognitive Subscale (ADAScog) is a psychometric instrument that includes 11 tasks and evaluates memory, attention, reasoning, language, orientation, and praxis, scored from 0 to 70. The full ADAS total is scored by summing the number of errors made on each task on a range from 0 to 150 so that higher scores indicate worse performance.The non-cognitive component was not used in this study. Obtained for correlation with neuroimaging biomarkers. |
| Neuropsychiatry Inventory - NPI | baseline to 6 months | NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 0 to 144; Higher scores indicate greater disease severity. Obtained for correlation with neuroimaging |
| ADCS Activities of Daily Living | baseline to 6 months | ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Obtained for correlation with neuroimaging |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo twice a day | 20 |
| Riluzole Riluzole 50mg twice a day | 22 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Riluzole | Total |
|---|---|---|---|
| Age, Continuous | 74.6 years STANDARD_DEVIATION 7.7 | 75.3 years STANDARD_DEVIATION 5.8 | 74.98 years STANDARD_DEVIATION 6.7 |
| Education | 15.1 years STANDARD_DEVIATION 3.1 | 15.9 years STANDARD_DEVIATION 3 | 15.5 years STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Black/non-Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Latino/Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/non-Hispanic | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 21 / 26 | 21 / 24 |
| serious Total, serious adverse events | 2 / 26 | 1 / 24 |
Outcome results
Primary
Imaging Biomarkers FDG-PET SUVR in Regions of Interest
Change from baseline to 6 months in cerebral glucose metabolism measured with FDG PET in posterior cingulate cortex, hippocampus, precuneus, and medial temporal, lateral temporal, inferior parietal, and frontal lobes, referred to collectively as our pre-specified regions of interest. Fluorodeoxyglucose (FDG)-positron emission tomography (PET) is an imaging procedure that measures glucose metabolism in the brain.It is a well-established Alzheimer's disease biomarker and predictor of disease progression. For each FDG PET scan, 5 mCi of fluorodeoxyglucose was administered followed by a 40 minute uptake period during which the participant was in a resting state. Images were acquired on a Siemens Biograph 64mCT scanner as a series of 4 frames of 5 minutes each. Using SPM12 (Wellcome Trust), motion correction was performed and frames averaged into a static image. Each 6 month scan was coregistered to the baseline FDG scan, which was co-registered to the participant's T1-weighted MRI scan.
Time frame: Change from baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Posterior cingulate | -0.048 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.035 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Precuneus | -0.032 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.028 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Temporal | -0.023 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.033 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Frontal | -0.129 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.066 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Parietal | -0.020 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.027 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Hippocampus | -0.018 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.034 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Right Hippocampus | -0.021 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.036 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | AD Progression score | 0.579 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.607 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Post Cing - Precuneus | -0.041 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.042 |
| Placebo | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Orbitofrontal | -0.019 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.044 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | AD Progression score | 0.245 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.558 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Posterior cingulate | -0.005 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.035 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Hippocampus | -0.002 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.029 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Precuneus | -0.007 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.032 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Orbitofrontal | 0.014 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.036 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Temporal | 0.002 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.029 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Right Hippocampus | 0.002 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.027 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Frontal | -0.077 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.072 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Post Cing - Precuneus | -0.006 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.038 |
| Riluzole | Imaging Biomarkers FDG-PET SUVR in Regions of Interest | Parietal | -0.005 Standardized Uptake Value Ratios (SUVRs) | Standard Deviation 0.024 |
Primary
Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS
N-acetylaspartate (NAA) is a neuronal viability marker measured through magnetic resonance spectroscopy (1H MRS).In vivo brain levels of NAA, glutamate, tCr and other major metabolites were obtained using 1H MRS and a 2x2x2-cm3 Posterior Cingulate Cortex (PC) voxel of interest in approximately 6.5 minutes using the constant-time point-resolved spectroscopy (CT-PRESS) technique with TE 30 ms, 129 constant-time increments (t1) of 0.8ms, and TR 1500 ms and a receive-only 8-channel phased-array head coil.The levels of NAA and other metabolites were expressed semi-quantitatively as ratios of peak areas relative to that of the unsuppressed water signal (W) from the same voxels. For consistency with earlier MRS literature, levels of the same metabolites were also expressed as peak ratios relative to tCr area in the same voxel.
Time frame: Changes from baseline to 6 months
Population: Some participants could not complete MRS study due to multiple reasons (eg could not tolerate lengthy exam, did not return to visit etc) or did complete it but quality control of the MRS spectra did not pass screening criteria for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | BASELINE (NAA/W) | 0.3843874 Ratios | Standard Deviation 0.0815156 |
| Placebo | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 3 MONTHS (NAA/W) | 0.3996655 Ratios | Standard Deviation 0.0927727 |
| Placebo | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 6 MONTHS (NAA/W) | 0.3784181 Ratios | Standard Deviation 0.0758756 |
| Placebo | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | BASELINE (NAA/tCr) | 1.4488809 Ratios | Standard Deviation 0.1731644 |
| Placebo | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 3 MONTHS (NAA/tCr) | 1.4271889 Ratios | Standard Deviation 0.114034 |
| Placebo | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 6 MONTHS (NAA/tCr) | 1.4594796 Ratios | Standard Deviation 0.145886 |
| Riluzole | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 3 MONTHS (NAA/tCr) | 1.4766125 Ratios | Standard Deviation 0.1304353 |
| Riluzole | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | BASELINE (NAA/W) | 0.4274546 Ratios | Standard Deviation 0.0684472 |
| Riluzole | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | BASELINE (NAA/tCr) | 1.4802620 Ratios | Standard Deviation 0.1412636 |
| Riluzole | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 3 MONTHS (NAA/W) | 0.4248429 Ratios | Standard Deviation 0.0774599 |
| Riluzole | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 6 MONTHS (NAA/tCr) | 1.4811814 Ratios | Standard Deviation 0.1474927 |
| Riluzole | Imaging Biomarkers N-acetylaspartate (NAA) in Posterior Cingulate (PC) Measured Through 1H MRS | 6 MONTHS (NAA/W) | 0.4415926 Ratios | Standard Deviation 0.103963 |
Secondary
ADCS Activities of Daily Living
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Obtained for correlation with neuroimaging
Time frame: baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | ADCS Activities of Daily Living | BASELINE | 68.3636364 score on a scale | Standard Deviation 9.5096215 |
| Placebo | ADCS Activities of Daily Living | 6 MONTHS | 65.5000000 score on a scale | Standard Deviation 11.5377228 |
| Riluzole | ADCS Activities of Daily Living | BASELINE | 68.0500000 score on a scale | Standard Deviation 9.3215935 |
| Riluzole | ADCS Activities of Daily Living | 6 MONTHS | 64.3000000 score on a scale | Standard Deviation 10.7757037 |
Secondary
Alzheimer's Disease Assessment Scale (ADAS) - Cognitive Subscale (ADAScog)
The ADAS comprises two subscales, cognitive and non-cognitive. The Cognitive Subscale (ADAScog) is a psychometric instrument that includes 11 tasks and evaluates memory, attention, reasoning, language, orientation, and praxis, scored from 0 to 70. The full ADAS total is scored by summing the number of errors made on each task on a range from 0 to 150 so that higher scores indicate worse performance.The non-cognitive component was not used in this study. Obtained for correlation with neuroimaging biomarkers.
Time frame: baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Alzheimer's Disease Assessment Scale (ADAS) - Cognitive Subscale (ADAScog) | BASELINE | 22.4981818 score on a scale | Standard Deviation 7.8875264 |
| Placebo | Alzheimer's Disease Assessment Scale (ADAS) - Cognitive Subscale (ADAScog) | 6 MONTHS | 21.8022727 score on a scale | Standard Deviation 9.7334313 |
| Riluzole | Alzheimer's Disease Assessment Scale (ADAS) - Cognitive Subscale (ADAScog) | BASELINE | 17.9005000 score on a scale | Standard Deviation 7.4614719 |
| Riluzole | Alzheimer's Disease Assessment Scale (ADAS) - Cognitive Subscale (ADAScog) | 6 MONTHS | 18.8495000 score on a scale | Standard Deviation 9.2608983 |
Secondary
Glutamate Levels Measured Through 1H MRS
In vivo measurement of glutamate with 1H magnetic resonance spectroscopy (MRS) (a neuroimaging study) in posterior cingulate as a marker of target engagement at three and six months compared to baseline.In vivo brain levels of glutamate, tCr and other major metabolites were obtained using 1H MRS and a 2x2x2-cm3 Posterior Cingulate Cortex voxel of interest in approximately 6.5 minutes using the constant-time point-resolved spectroscopy (CT-PRESS) technique with TE 30 ms, 129 constant-time increments (t1) of 0.8ms, and TR 1500 ms and a receive-only 8-channel phased-array head coil.The levels of glutamate and other metabolites were expressed semi-quantitatively as ratios of peak areas relative to that of the unsuppressed water signal (W) from the same voxels. For consistency with earlier MRS literature, levels of the same metabolites were also expressed as peak ratios relative to tCr area in the same voxel.
Time frame: Change from baseline to 6 months
Population: Some participants could not complete MRS study due to multiple reasons (eg could not tolerate lengthy exam, did not return to visit etc) or did complete it but quality control of the MRS spectra did not pass screening criteria for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Glutamate Levels Measured Through 1H MRS | BASELINE (Glu/W) | 0.0598059 Ratios | Standard Deviation 0.0164069 |
| Placebo | Glutamate Levels Measured Through 1H MRS | 3 MONTHS (Glu/W) | 0.0579899 Ratios | Standard Deviation 0.018104 |
| Placebo | Glutamate Levels Measured Through 1H MRS | 6 MONTHS (Glu/W) | 0.0609985 Ratios | Standard Deviation 0.015696 |
| Placebo | Glutamate Levels Measured Through 1H MRS | BASELINE (Glu/tCr) | 0.2280186 Ratios | Standard Deviation 0.0543718 |
| Placebo | Glutamate Levels Measured Through 1H MRS | 3 MONTHS (Glu/tCr) | 0.2080647 Ratios | Standard Deviation 0.051516 |
| Placebo | Glutamate Levels Measured Through 1H MRS | 6 MONTHS (Glu/tCr) | 0.2339366 Ratios | Standard Deviation 0.0370164 |
| Riluzole | Glutamate Levels Measured Through 1H MRS | 3 MONTHS (Glu/tCr) | 0.2285644 Ratios | Standard Deviation 0.0441709 |
| Riluzole | Glutamate Levels Measured Through 1H MRS | BASELINE (Glu/W) | 0.0677906 Ratios | Standard Deviation 0.0133271 |
| Riluzole | Glutamate Levels Measured Through 1H MRS | BASELINE (Glu/tCr) | 0.2367567 Ratios | Standard Deviation 0.0484442 |
| Riluzole | Glutamate Levels Measured Through 1H MRS | 3 MONTHS (Glu/W) | 0.0646162 Ratios | Standard Deviation 0.0107094 |
| Riluzole | Glutamate Levels Measured Through 1H MRS | 6 MONTHS (Glu/tCr) | 0.2162526 Ratios | Standard Deviation 0.042614 |
| Riluzole | Glutamate Levels Measured Through 1H MRS | 6 MONTHS (Glu/W) | 0.0633453 Ratios | Standard Deviation 0.0147764 |
Secondary
Neuropsychiatry Inventory - NPI
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 0 to 144; Higher scores indicate greater disease severity. Obtained for correlation with neuroimaging
Time frame: baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Neuropsychiatry Inventory - NPI | BASELINE | 9.6363636 score on a scale | Standard Deviation 9.1627894 |
| Placebo | Neuropsychiatry Inventory - NPI | 6 MONTHS | 9.0909091 score on a scale | Standard Deviation 6.6254135 |
| Riluzole | Neuropsychiatry Inventory - NPI | BASELINE | 10.2000000 score on a scale | Standard Deviation 11.1383642 |
| Riluzole | Neuropsychiatry Inventory - NPI | 6 MONTHS | 14.0500000 score on a scale | Standard Deviation 12.8082005 |