Back to resultsStudy to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation
Primary Purpose
Mild Cognitive Impairment (MCI), Alzheimer Disease, Dementia
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
XPro1595
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment (MCI) focused on measuring Inflammation, Biomarker, Tumor Necrosis Factor (TNF)
Eligibility Criteria
Inclusion Criteria:
Patients are eligible to be included in the study only if all the following criteria apply:
- Adult male and female patients ≥ 55 years to ≤ 80 years of age at the time of consent;
- Diagnosed with MCI of probable Alzheimer's disease (Albert 2011; National Institute on Aging - Alzheimer's Association [NIA-AA]). Patients who have received previous therapy for Alzheimer's disease may still be eligible;
- Amyloid positive (documented in medical history or assessed during screening through blood test);
- Literate and capable of reading, writing, and communicating effectively with others, based on the PI's assessment;
- Has a study partner willing to participate for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which informant assessments are performed.
Exclusion Criteria:
- Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners at the strength required for this study);
- Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility;
- Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer's prodrome. History of suicidality: has answered "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, at Screening, or at the Week 1 Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening;
- History of substance abuse within 12 months; use of cannabis or cannabis products within 6 months of consent;
- Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have received treatment on another AD clinical trial within the last 60 days from Day 1
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1.0 mg/kg XPro1595
1.0 mg/kg Placebo
Arm Description
1.0 mg/kg XPro1595 will be administered via subcutaneous injection once a week for 12 weeks.
1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 12 weeks.
Outcomes
Primary Outcome Measures
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
Change from Baseline to Week 12 in the Early and Mild Alzheimer's Cognitive Composite (EMACC) (Jaeger 2017) made up of the following tests:
International Shopping List Test- Immediate recall (Word List Learning Test-Immediate recall)
Trail Making Test Part A and B
Digit Symbol Coding Test
Digit Span Forward and Backward
Category Fluency Test (DKEFS)
Letter Fluency Test (DKEFS)
To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI
Secondary Outcome Measures
Change in Mean Computer-based Cognitive Assessment (Cogstate) Composite score from Screening to Week 12
Change from Screening to Week 12 in Cogstate Composite mean score.
Cogstate is a brief, computerized, neuropsychological battery to evaluate cognitive impairments in mild cognitive impairment (MCI), and Alzheimer's disease (AD). CogState assesses attention and memory functions - including Information processing speed, Visual attention, Working memory and Visual learning. Cogstate scores are measured on a linear scale (with no maximum score). A reduction in scores compared to baseline signifies an improvement in cognitive functions.
The Cogstate battery will be administered at Screening and each week for 12 weeks.
To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI
Change in myelin content
Change from Screening to Week 12 in myelin content.
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
Change from Screening to Week 12 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
Change from Screening to Week 12 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
Change in Imaging (MRI) Neuroinflammation
Change from Screening to Week 12 in MRI neuroinflammation (White matter Free Water)
To assess the efficacy of XPro1595 compared with placebo on imaging neuroinflammation
Change in imaging markers of brain quality
Change from Screening to Week 12 in regional brain glucose uptake as measured by F-fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scans
Alzheimer's Disease (AD) is characterized by a chronic brain glucose deficit. White matter glucose deterioration is also evident in Mild Cognitive Impairment (MCI) and specific to limbic fascicles. We will quantify the change in regional brain glucose uptake for gray matter and white matter tracts using PET imaging and the F-fluorodeoxyglucose (FDG) radiotracer. PET maps will be registered to Magnetic Resonance (MR) anatomical images and corrected for partial volume effect. Standard uptake value ratios (SUVr) will be calculated using the cerebellum as a reference region.
FDG-PET scans will be performed at Screening and Week 12.
To assess the efficacy of XPro1595 compared with placebo on imaging markers of brain quality
Change in apparent fiber density (AFD)
Change from Baseline to Week 12 in MRI Apparent Fiber Density (AFD)
To assess the efficacy of XPro1595 compared with placebo on axonal integrity in patients with MCI
Change in non-cognitive behavioral symptoms
Change from Screening to Week 12 in Neuropsychiatric Inventory (NPI-12) study partner items
To assess the effect of XPro1595 compared with placebo on non-cognitive behavioral symptoms in patients with MCI
Change in brain activity
Change from Screening to Week 12 in brain activity as measured by electroencephalogram (EEG) scans (Change in brain activity as measured by the EEG in microvolts).
Specifically, a series of EEG markers previously associated with AD (Horvath et al. 2018) including high and low frequency band powers, the P300, and Mismatch Negativity (MMN) event-related potentials will be evaluated.
An EEG scan will be administered at Screening and each week for 12 weeks.
To assess the efficacy of XPro1595 compared with placebo on brain activity in patients with MCI
Change in speech and language
Change from Baseline to Week 12 in language and speech patterns using Winterlight Labs analysis
To assess the effect of XPro1595 compared with placebo on speech and language in patients with MCI
Change in Alzheimer's Disease Cooperative Study - Mild Cognitive Impairment Activities of Daily Living (ADCS-MCI ADL)
Change from Screening to Week 12 in Alzheimer's Disease Cooperative Study - Mild Cognitive Impairment Activities of Daily Living (ADCS-MCI ADL)
The 23-item ADCS-MCI-ADL Scale has good test-retest reliability, will be utilized to assess performance functioning in MCI patients (Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The ADCS-ADL includes 18 items from traditional basic ADL scales and 5 items from instrumental activities of daily living scales (IADL) The possible range of total scores for the ADL Scale is 0-53 and higher scores indicate better functioning. The internal reliability was .91( Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010).
The ADCS-MCI ADL will be performed at Screening and Week 12.
To assess the effect of XPro1595 compared with placebo on Activities of Daily Living (ADL) in patients with MCI
Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Change from Screening to Week 12 in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
The CDR scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None = 0, Questionable = 0.5, Mild = 1, Moderate = 2, and Severe = 3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
To assess the effect of XPro1595 compared with placebo on cognition and global function in patients with MCI
Number of participants who experience adverse events and serious adverse events
Clinically significant abnormalities of laboratory values, physical findings, electrocardiogram findings and other safety assessments will be recorded as adverse events if the findings meet the defined criteria for adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05321498
Brief Title
Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation
Official Title
A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Mild Cognitive Impairment (MCI) With Biomarkers of Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
MCI patients will now be enrolled in the XPro1595-AD-02 study.
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
October 26, 2023 (Anticipated)
Study Completion Date
October 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmune Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this Phase 2 MCI study is to determine whether 1.0 mg/kg XPro1595 is superior to placebo at improving measures of cognition, functioning and brain quality in individuals with MCI and biomarkers associated with neuroinflammation (APOE4) and to evaluate safety, tolerability, and efficacy of XPro1595.
Detailed Description
This study is designed as a Phase 2, double-blind randomized, placebo-controlled study investigating the safety, tolerability, and efficacy of XPro1595 in patients with MCI. The planned dose is 1.0 mg/kg of XPro1595 and matching placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI), Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Mental Disorders
Keywords
Inflammation, Biomarker, Tumor Necrosis Factor (TNF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
(2:1) XPro1595 (1mg/kg), placebo
Weekly subcutaneous injections
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.0 mg/kg XPro1595
Arm Type
Experimental
Arm Description
1.0 mg/kg XPro1595 will be administered via subcutaneous injection once a week for 12 weeks.
Arm Title
1.0 mg/kg Placebo
Arm Type
Placebo Comparator
Arm Description
1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
XPro1595
Other Intervention Name(s)
INB03/XPro™, XENP1595, Dominant-negative Tumor Necrosis Factor (DN-TNF)
Intervention Description
XPro1595 will be delivered by subcutaneous injection once a week.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Placebo will be delivered by subcutaneous injection once a week
Primary Outcome Measure Information:
Title
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
Description
Change from Baseline to Week 12 in the Early and Mild Alzheimer's Cognitive Composite (EMACC) (Jaeger 2017) made up of the following tests:
International Shopping List Test- Immediate recall (Word List Learning Test-Immediate recall)
Trail Making Test Part A and B
Digit Symbol Coding Test
Digit Span Forward and Backward
Category Fluency Test (DKEFS)
Letter Fluency Test (DKEFS)
To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in Mean Computer-based Cognitive Assessment (Cogstate) Composite score from Screening to Week 12
Description
Change from Screening to Week 12 in Cogstate Composite mean score.
Cogstate is a brief, computerized, neuropsychological battery to evaluate cognitive impairments in mild cognitive impairment (MCI), and Alzheimer's disease (AD). CogState assesses attention and memory functions - including Information processing speed, Visual attention, Working memory and Visual learning. Cogstate scores are measured on a linear scale (with no maximum score). A reduction in scores compared to baseline signifies an improvement in cognitive functions.
The Cogstate battery will be administered at Screening and each week for 12 weeks.
To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI
Time Frame
12 Weeks
Title
Change in myelin content
Description
Change from Screening to Week 12 in myelin content.
Time Frame
12 Weeks
Title
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
Description
Change from Screening to Week 12 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
Time Frame
12 Weeks
Title
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
Description
Change from Screening to Week 12 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
Time Frame
12 Weeks
Title
Change in Imaging (MRI) Neuroinflammation
Description
Change from Screening to Week 12 in MRI neuroinflammation (White matter Free Water)
To assess the efficacy of XPro1595 compared with placebo on imaging neuroinflammation
Time Frame
12 Weeks
Title
Change in imaging markers of brain quality
Description
Change from Screening to Week 12 in regional brain glucose uptake as measured by F-fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scans
Alzheimer's Disease (AD) is characterized by a chronic brain glucose deficit. White matter glucose deterioration is also evident in Mild Cognitive Impairment (MCI) and specific to limbic fascicles. We will quantify the change in regional brain glucose uptake for gray matter and white matter tracts using PET imaging and the F-fluorodeoxyglucose (FDG) radiotracer. PET maps will be registered to Magnetic Resonance (MR) anatomical images and corrected for partial volume effect. Standard uptake value ratios (SUVr) will be calculated using the cerebellum as a reference region.
FDG-PET scans will be performed at Screening and Week 12.
To assess the efficacy of XPro1595 compared with placebo on imaging markers of brain quality
Time Frame
12 Weeks
Title
Change in apparent fiber density (AFD)
Description
Change from Baseline to Week 12 in MRI Apparent Fiber Density (AFD)
To assess the efficacy of XPro1595 compared with placebo on axonal integrity in patients with MCI
Time Frame
12 Weeks
Title
Change in non-cognitive behavioral symptoms
Description
Change from Screening to Week 12 in Neuropsychiatric Inventory (NPI-12) study partner items
To assess the effect of XPro1595 compared with placebo on non-cognitive behavioral symptoms in patients with MCI
Time Frame
12 Weeks
Title
Change in brain activity
Description
Change from Screening to Week 12 in brain activity as measured by electroencephalogram (EEG) scans (Change in brain activity as measured by the EEG in microvolts).
Specifically, a series of EEG markers previously associated with AD (Horvath et al. 2018) including high and low frequency band powers, the P300, and Mismatch Negativity (MMN) event-related potentials will be evaluated.
An EEG scan will be administered at Screening and each week for 12 weeks.
To assess the efficacy of XPro1595 compared with placebo on brain activity in patients with MCI
Time Frame
12 Weeks
Title
Change in speech and language
Description
Change from Baseline to Week 12 in language and speech patterns using Winterlight Labs analysis
To assess the effect of XPro1595 compared with placebo on speech and language in patients with MCI
Time Frame
12 Weeks
Title
Change in Alzheimer's Disease Cooperative Study - Mild Cognitive Impairment Activities of Daily Living (ADCS-MCI ADL)
Description
Change from Screening to Week 12 in Alzheimer's Disease Cooperative Study - Mild Cognitive Impairment Activities of Daily Living (ADCS-MCI ADL)
The 23-item ADCS-MCI-ADL Scale has good test-retest reliability, will be utilized to assess performance functioning in MCI patients (Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The ADCS-ADL includes 18 items from traditional basic ADL scales and 5 items from instrumental activities of daily living scales (IADL) The possible range of total scores for the ADL Scale is 0-53 and higher scores indicate better functioning. The internal reliability was .91( Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010).
The ADCS-MCI ADL will be performed at Screening and Week 12.
To assess the effect of XPro1595 compared with placebo on Activities of Daily Living (ADL) in patients with MCI
Time Frame
12 Weeks
Title
Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Description
Change from Screening to Week 12 in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
The CDR scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None = 0, Questionable = 0.5, Mild = 1, Moderate = 2, and Severe = 3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
To assess the effect of XPro1595 compared with placebo on cognition and global function in patients with MCI
Time Frame
12 Weeks
Title
Number of participants who experience adverse events and serious adverse events
Description
Clinically significant abnormalities of laboratory values, physical findings, electrocardiogram findings and other safety assessments will be recorded as adverse events if the findings meet the defined criteria for adverse events.
Time Frame
Screening up to 28 days post last dose
Other Pre-specified Outcome Measures:
Title
Change in Goal Attainment Scale (GAS)
Description
Change in Goal Attainment Scale (GAS)
The achievement of each goal is rated on a 5-point attainment scale (-2, -1, 0, +1, +2) to allow standardized scoring of personalized outcomes. A participant's overall goal attainment is quantified using a formula that takes into account the number of goals that have been set, and the extent to which they are correlated with each other. For each identified goal area, the caregiver will be asked to give a detailed description of the patient's current (baseline) status and goal status, which will be recorded at the -1 and 0 levels on the 5-point scale, respectively. The remaining levels of the scale will then be set: somewhat better than the goal (+1), much better than the goal (+2), and much worse than the goal (-2).
To evaluate the effect of XPro1595 compared with placebo on goal attainment scores
Time Frame
12 Weeks
Title
Change in measures of activity
Description
Change from Screening to Week 12 in activity metrics (time spent lying, sitting, standing, stepping, upright, in walking bouts, in-context specific walking bouts; number of steps, and sit-to-stand transitions) as measured by the activity monitor. Physical activity will be measured in real time using the activity monitor worn on the patient's wrist. Total activity counts per minute (higher activity counts = more activity) and number of steps taken will be derived from data. Patients will be equipped with the monitoring device during the screening period and activity metrics will be measured for 7 days prior to each EMACC assessment. Data will be measured at Screening, Week 1, Week 3, Week 6, Week 9 and Week 12.
To assess the effect of XPro1595 compared to placebo on measures of activity
Time Frame
12 Weeks
Title
Evaluate predictability of patient response after placebo administration and potential influence of study partners on outcome evaluation using the Multidimensional Psychological Questionnaire (MPsQ) with a 5 point scale
Description
The Multidimensional Psychological Questionnaire (MPsQ) questionnaires have been designed to specifically measure patient personality characteristics associated with the placebo response. The MPsQ questionnaires are self-reported, and each item is rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).
MPsQs will be completed by the patient and separate MPsQs will be completed by the study partner at screening.
MPsQs will be completed by the patient and separate MPsQs will be completed by the study partner prior to investigational product administration.
The patient and study partner will complete MPsQs at Screening and Week 1.
To measure patient personality characteristics associated with the placebo response.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are eligible to be included in the study only if all the following criteria apply:
Adult male and female patients ≥ 55 years to ≤ 80 years of age at the time of consent;
Diagnosed with MCI of probable Alzheimer's disease (Albert 2011; National Institute on Aging - Alzheimer's Association [NIA-AA]). Patients who have received previous therapy for Alzheimer's disease may still be eligible;
Amyloid positive (documented in medical history or assessed during screening through blood test);
Literate and capable of reading, writing, and communicating effectively with others, based on the PI's assessment;
Has a study partner willing to participate for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which informant assessments are performed.
Exclusion Criteria:
Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners at the strength required for this study);
Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility;
Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer's prodrome. History of suicidality: has answered "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, at Screening, or at the Week 1 Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening;
History of substance abuse within 12 months; use of cannabis or cannabis products within 6 months of consent;
Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have received treatment on another AD clinical trial within the last 60 days from Day 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Lehner
Organizational Affiliation
INmune Bio
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16569464
Citation
Alvarez A, Cacabelos R, Sanpedro C, Garcia-Fantini M, Aleixandre M. Serum TNF-alpha levels are increased and correlate negatively with free IGF-I in Alzheimer disease. Neurobiol Aging. 2007 Apr;28(4):533-6. doi: 10.1016/j.neurobiolaging.2006.02.012. Epub 2006 Mar 29.
Results Reference
background
PubMed Identifier
16705109
Citation
Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006 May 17;295(19):2275-85. doi: 10.1001/jama.295.19.2275. Erratum In: JAMA. 2006 Jun 7;295(21):2482.
Results Reference
background
PubMed Identifier
19070941
Citation
Buchhave P, Zetterberg H, Blennow K, Minthon L, Janciauskiene S, Hansson O. Soluble TNF receptors are associated with Abeta metabolism and conversion to dementia in subjects with mild cognitive impairment. Neurobiol Aging. 2010 Nov;31(11):1877-84. doi: 10.1016/j.neurobiolaging.2008.10.012. Epub 2008 Dec 13.
Results Reference
background
PubMed Identifier
21239393
Citation
Chance SA, Clover L, Cousijn H, Currah L, Pettingill R, Esiri MM. Microanatomical correlates of cognitive ability and decline: normal ageing, MCI, and Alzheimer's disease. Cereb Cortex. 2011 Aug;21(8):1870-8. doi: 10.1093/cercor/bhq264. Epub 2011 Jan 14.
Results Reference
background
Links:
URL
https://www.alz.org/alzheimers-dementia/facts-figures
Description
Alzheimer's Association annual report releasing statistics regarding Alzheimer's disease
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Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation
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