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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
| Amsterdam UMC, location VUmc | OTHER |
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This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate significant improvement relative to placebo-treatment in episodic memory function, as assessed by the Hopkins Verbal Learning Test. Secondary endpoints include Clinical Dementia Rating scale (CDR), Wechsler Memory Scale (WMS), Mini-Mental-Status-Examination (MMSE) and Cerebrospinal fluid (CSF) biomarkers of AD disease activity and progression.
Details provided elsewhere.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neflamapimod | Experimental | 40 mg hard gelatin capsules, taken twice daily with food. |
|
| placebo | Placebo Comparator | hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neflamapimod | Drug | 40 mg neflamapimod capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total and Delayed Recall on the Hopkins Verbal Learning Test - Revised (HVLT-R) | Combined change from baseline in z-scores of total and delayed recall on the Hopkins Verbal Learning Test - Revised (HVLT-R) in neflamapimod-treated subjects compared to placebo. The primary endpoint was analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. For baseline total and delayed recall, a z-score for each subject is defined by z=(x-m)/s where x is the subject's recall at baseline, and m and s are the overall mean and overall standard deviation of recall at baseline across all subjects. A composite baseline z-score for each subject is calculated using equal weighting in the following way: Z=0.5*z-score for total recall at baseline + 0.5*z-score for delayed recall at baseline. For HVLT-R, higher score indicates improvement. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Memory Scale (WMS) Immediate and Delayed Recall | Change from baseline in Wechsler Memory Scale(WMS) immediate and delayed recall composites in neflamapimod-treated subjects compared to placebo. WMS scores were analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. Composite scores for immediate and delayed recall are the combination of all immediate and delayed recall task raw scores and ranges from 0-228. A higher score indicates improvement. The following tests in WMS are done both for immediate and delayed recall: Logical Memory test, in which subject is read a story; Verbal-Paired Associates, in which subject is given pairs of words and asked remember which words go together; and Visual Reproduction, in which subject is given drawings of specific shapes |
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Inclusion Criteria:
Men and women age 55 to 85 years, inclusive.
Willing and able to provide informed consent.
Must have mild cognitive impairment (MCI) or mild AD with evidence of progression ("Mild-AD"), as defined by the following:
Computed tomography (CT) or magnetic resonance imaging (MRI) findings within 2 years of Screening that are compatible with AD and no other pathologic processes that might potentially account for the subject's cognitive impairment.
If the subject is taking a single drug for AD (e.g., donepezil or other cholinesterase inhibitors or memantine; dual therapy is excluded), he/she has been on a stable dose for at least 2 months prior to baseline, and the dose must remain unchanged during the study unless required for management of adverse events (AEs).
Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
Must have reliable informant or caregiver.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Alam, MD | EIP Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Research | Long Beach | California | 90807 | United States | ||
| Pacific Research Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34044875 | Derived | Prins ND, Harrison JE, Chu HM, Blackburn K, Alam JJ, Scheltens P; REVERSE-SD Study Investigators. A phase 2 double-blind placebo-controlled 24-week treatment clinical study of the p38 alpha kinase inhibitor neflamapimod in mild Alzheimer's disease. Alzheimers Res Ther. 2021 May 27;13(1):106. doi: 10.1186/s13195-021-00843-2. | |
| 33974419 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Arm | Arm of trial including the 83 subjects that were randomly assigned (1:1) to take placebo |
| FG001 | Neflamapimod Arm | Arm of trial including the 78 subjects that were randomly assigned (1:1) to take neflamapimod (active study drug). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2018 | Jul 23, 2020 |
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Double-blind, placebo-controlled
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| placebo | Other | matching placebo capsule |
|
| Baseline and 24 weeks |
| Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) | Change from baseline in total score of Clinical Dementia Rating Scale - Sum of Boxes (range 0-18) in neflamapimod-treated subjects compared to placebo. CDR-SB scores were analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. CDR-SB score is calculated by adding the individual scores from 6 domains, Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB scores range from 0-18, where a lower score indicates improvement. The scale is administered in a semi-structured interview format with both the patient and the caregiver/informant. | Baseline and 24 weeks |
| Mini-Mental State Examination (MMSE) | Changes from baseline in Mini-Mental State Examination (MMSE) scores were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. The MMSE is scored from 0-30 with a higher score indicating improvement. The MMSE includes questions that test orientation, attention, memory, language and visual-spatial skills. | Baseline and 26 Weeks (Follow-up visit, 2 weeks from end of dosing) |
| Cerebrospinal Fluid Total Tau | Change from, baseline in Total Tau (t-tau) were compared using an ANCOVA with treatment group, background ADspecific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | Baseline and 24 weeks |
| Cerebrospinal Fluid Phospho-tau | Change from baseline in Phospho-Tau (p-tau181) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | Baseline and 24 weeks |
| Cerebrospinal Fluid Amyloid Beta 1-40 | Change from baseline in Amyloid beta (AB1-40) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | Baseline and 24 weeks |
| Cerebrospinal Fluid Amyloid Beta 1-42 | Change from baseline in Amyloid beta (AB1-42) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | Baseline and 24 weeks |
| Cerebrospinal Fluid Neurogranin | Change from baseline in Neurogranin were compared using an ANCOVA with treatment group, background ADspecific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | Baseline and 24 weeks |
| Cerebrospinal Fluid Neurofilament Light Chain | Change from baseline in Neurofilament Light Chain (NFL) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | Baseline and 24 weeks |
| Cerebrospinal Fluid P-tau/AB1-42 Ratio | Changes in the ratio of Phospho-Tau/Amyloid Beta (p-tau181/AB1-42) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | Baseline and 24 weeks |
| San Diego |
| California |
| 92103 |
| United States |
| CITrials | Santa Ana | California | 92705 | United States |
| Southern California Research, LLC | Simi Valley | California | 93065 | United States |
| Viking Clinical Research | Temecula | California | 92591 | United States |
| Miami Dade Medical Research Institute | Miami | Florida | 33176 | United States |
| Sensible Healthcare, LLC | Ocoee | Florida | 34761 | United States |
| Anchor Neuroscience | Pensacola | Florida | 32502 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Suncoast Neuroscience Associates, Inc. | St. Petersburg | Florida | 33713 | United States |
| Florida Premier Research Institute | Winter Park | Florida | 32789 | United States |
| Northwest Clinical Trials | Boise | Idaho | 83704 | United States |
| MassGeneral Institute for Neurodegenerative Disease | Charlestown | Massachusetts | 02129 | United States |
| Manhattan Behavioral Medicine | New York | New York | 10036 | United States |
| Alzheimer's Memory Center and Research Institute | Charlotte | North Carolina | 28270 | United States |
| Northwest Clinical Research Center | Seattle | Washington | 98007 | United States |
| Neuro HK, s.r.o. POLIKLINIKA CHOCEŇ, a.s. | Choceň | 565 01 | Czechia |
| Cerebrovaskulární poradna s.r.o. | Moravská Ostrava | 702 00 | Czechia |
| Clintrial S.R.O | Prague | 100 00 | Czechia |
| Private Psychiatric Centre | Prague | 109 00 | Czechia |
| Vestra Clinics S.R.O | Rychnov nad Kněžnou | 516 01 | Czechia |
| CCBR Clinical Research, Aalborg | Aalborg | DK-9000 | Denmark |
| CCBR Clinical Research, Ballerup | Ballerup Municipality | DK-2750 | Denmark |
| CCBR Clinical Research, Vejle | Vejle | DK-7100 | Denmark |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Alzheimer Research Center | Amsterdam | 1081 GM | Netherlands |
| Amphia Ziekhuis | Breda | 4817 CK | Netherlands |
| MAC Clinical Research Tankersley | Barnsley | S75 3DL | United Kingdom |
| Re:Cognition Health Birmingham | Birmingham | B16 8LT | United Kingdom |
| MAC Clinical Research Blackpool | Blackpool | FY2 0JH | United Kingdom |
| Fulbourn Hospital | Cambridge | CB21 5EF | United Kingdom |
| MAC Clinical Research Leeds | Leeds | LS10 1DU | United Kingdom |
| MAC Clinical Research Liverpool | Liverpool | L34 1BH | United Kingdom |
| Re:Cognition Health London | London | W1G 9JF | United Kingdom |
| St. Pancras Clinical Research | London | WC1X 8QD | United Kingdom |
| MAC Clinical Research Manchester | Manchester | M13 9NQ | United Kingdom |
| Re:Cognition Health Plymouth | Plymouth | PL5 8BT | United Kingdom |
| 5 Boroughs/North West Boroughs Healthcare NHS Foundation Trust | Warrington | WA22 8WA | United Kingdom |
| Tormahlen NM, Martorelli M, Kuhn A, Maier F, Guezguez J, Burnet M, Albrecht W, Laufer SA, Koch P. Design and Synthesis of Highly Selective Brain Penetrant p38alpha Mitogen-Activated Protein Kinase Inhibitors. J Med Chem. 2022 Jan 27;65(2):1225-1242. doi: 10.1021/acs.jmedchem.0c01773. Epub 2021 May 11. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Arm | Arm of trial including the 83 subjects that were randomly assigned (1:1) to take placebo |
| BG001 | Neflamapimod Arm | Arm of trial including the 78 subjects that were randomly assigned (1:1) to take neflamapimod (active study drug). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Mean | Full Range | Kg |
|
| 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 | Total and Delayed Recall on the Hopkins Verbal Learning Test - Revised (HVLT-R) | Combined change from baseline in z-scores of total and delayed recall on the Hopkins Verbal Learning Test - Revised (HVLT-R) in neflamapimod-treated subjects compared to placebo. The primary endpoint was analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. For baseline total and delayed recall, a z-score for each subject is defined by z=(x-m)/s where x is the subject's recall at baseline, and m and s are the overall mean and overall standard deviation of recall at baseline across all subjects. A composite baseline z-score for each subject is calculated using equal weighting in the following way: Z=0.5*z-score for total recall at baseline + 0.5*z-score for delayed recall at baseline. For HVLT-R, higher score indicates improvement. | All participants who had analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | Z-score | Baseline and 24 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Wechsler Memory Scale (WMS) Immediate and Delayed Recall | Change from baseline in Wechsler Memory Scale(WMS) immediate and delayed recall composites in neflamapimod-treated subjects compared to placebo. WMS scores were analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. Composite scores for immediate and delayed recall are the combination of all immediate and delayed recall task raw scores and ranges from 0-228. A higher score indicates improvement. The following tests in WMS are done both for immediate and delayed recall: Logical Memory test, in which subject is read a story; Verbal-Paired Associates, in which subject is given pairs of words and asked remember which words go together; and Visual Reproduction, in which subject is given drawings of specific shapes | All participants who had analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | Scores on a scale | Baseline and 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) | Change from baseline in total score of Clinical Dementia Rating Scale - Sum of Boxes (range 0-18) in neflamapimod-treated subjects compared to placebo. CDR-SB scores were analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. CDR-SB score is calculated by adding the individual scores from 6 domains, Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB scores range from 0-18, where a lower score indicates improvement. The scale is administered in a semi-structured interview format with both the patient and the caregiver/informant. | All participants who had analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | Scores on a scale | Baseline and 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mini-Mental State Examination (MMSE) | Changes from baseline in Mini-Mental State Examination (MMSE) scores were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. The MMSE is scored from 0-30 with a higher score indicating improvement. The MMSE includes questions that test orientation, attention, memory, language and visual-spatial skills. | All participants who had analyzable results at Baseline and Follow-up Visit (2 weeks post-treatment) | Posted | Mean | Standard Error | Scores on a scale | Baseline and 26 Weeks (Follow-up visit, 2 weeks from end of dosing) |
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| Secondary | Cerebrospinal Fluid Total Tau | Change from, baseline in Total Tau (t-tau) were compared using an ANCOVA with treatment group, background ADspecific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | All participants with analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | pg/mL | Baseline and 24 weeks |
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| Secondary | Cerebrospinal Fluid Phospho-tau | Change from baseline in Phospho-Tau (p-tau181) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | All participants who had analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | pg/mL | Baseline and 24 weeks |
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| Secondary | Cerebrospinal Fluid Amyloid Beta 1-40 | Change from baseline in Amyloid beta (AB1-40) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | All participants who had analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | pg/mL | Baseline and 24 weeks |
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| Secondary | Cerebrospinal Fluid Amyloid Beta 1-42 | Change from baseline in Amyloid beta (AB1-42) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | All participants who had analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | pg/mL | Baseline and 24 weeks |
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| Secondary | Cerebrospinal Fluid Neurogranin | Change from baseline in Neurogranin were compared using an ANCOVA with treatment group, background ADspecific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | All participants with analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | pg/mL | Baseline and 24 weeks |
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| Secondary | Cerebrospinal Fluid Neurofilament Light Chain | Change from baseline in Neurofilament Light Chain (NFL) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | All participants with analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | pg/mL | Baseline and 24 weeks |
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| Secondary | Cerebrospinal Fluid P-tau/AB1-42 Ratio | Changes in the ratio of Phospho-Tau/Amyloid Beta (p-tau181/AB1-42) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. | All participants with analyzable results at Baseline and Week 24 | Posted | Mean | Standard Error | ratio | Baseline and 24 weeks |
|
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Up to 29 weeks. AEs occurring from when the subject signed the ICF until up to 30 days after the last dose were collected. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history.
Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsen after starting the treatment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Arm | Arm of trial including the 83 subjects that were randomly assigned (1:1) to take placebo | 0 | 83 | 3 | 83 | 16 | 83 |
| EG001 | Neflamapimod Arm | Arm of trial including the 78 subjects that were randomly assigned (1:1) to take neflamapimod (active study drug). | 0 | 78 | 2 | 78 | 18 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Non-systematic Assessment | Multiple Myeloma occurred in one subject. It was not considered related to neflamapimod. |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment | One SAE of Hypokalemia was reported. It was considered not related to neflamapimod. |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Conway, Associate Director of Clinical Development | EIP Pharma | (617) 744-4400 | jconway@eippharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2019 | Jul 23, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C464966 | VX-745 |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| United States |
|
| Czechia |
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| Denmark |
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| United Kingdom |
|
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