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| ID | Type | Description | Link |
|---|---|---|---|
| ADC-042-DISC | Other Identifier | Alzheimer's Disease Cooperative Study (ADCS) |
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| Name | Class |
|---|---|
| Alzheimer's Disease Cooperative Study (ADCS) | OTHER |
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This study evaluates the safety and pharmacological effects of 3 different doses of Posiphen® when compared to a placebo, in adult male and female patients with early Alzheimer's disease (AD).
Posiphen®, which was discovered by the US National Institute on Aging (NIA) is a small, orally active, experimental drug that specifically inhibits the synthesis of amyloid precursor protein (APP), Tau and α-Synuclein. It is distinct from other Alzheimer's disease drugs currently in development, because it inhibits the formation of several toxic proteins, rather than removing individual toxic protein after they are produced. Posiphen has potential utility as a disease modifying treatment for AD. The present study will confirm the pharmacokinetics (PK) of Posiphen and its metabolites in plasma and cerebral spinal fluid (CSF). It will also measure the effects of a 23-25 day treatment period with Posiphen on the CSF and plasma levels of a number of biomarkers, inflammatory factors and control proteins. It will also expand the safety data in humans by extending the treatment period from 10 days to a treatment period from 23-25 days. In addition, this study will measure concentrations of various soluble biomarkers in CSF and use the SILK™ assay methods to directly measure the effect of Posiphen on the fractional synthesis rate of Aβ40 in CSF, which will help guide the further development of Posiphen and determine the feasibility of SILK™ in a multicenter trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days. |
|
| Medium Dose | Experimental | The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days. |
|
| High Dose | Experimental | The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days. |
|
| Placebo | Placebo Comparator | The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posiphen | Drug | oral solid dosage form capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Multiple Ascending Doses of Posiphen: Reports of Adverse Events or Study Discontinuations | Number of adverse events or study discontinuations, broken down by dose arm (i.e. Low vs. Medium vs. High vs. Placebo), and further broken down by relatedness to Posiphen (Definitely Related, Probably Related, Possibly Related, Unlikely Related, Unrelated) | Up to 25 days |
| The Levels of Posiphen and Its Metabolites Will be Determined in Plasma | Mean plasma concentrations of levels of posiphen tartrate, N1 desmethyl posiphen, and N8 desmethyl Posiphen metabolite were determined for each of the three dose cohorts (Low Dose, Medium Dose, High Dose) by a protein precipitation extraction method using a high performance liquid chromatographic mass spectrometric detection method, with a linear weighted regression to determine their concentrations. | The confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. Plasma was collected at 0, 2, 4, 8, 12, 16, 20, and 24hrs during the confinement visit. |
| The Levels of Posiphen and Its Metabolites Will be Determined in Cerebrospinal Fluid (CSF) | Mean CSF concentrations of levels of posiphen tartrate, N1 desmethyl posiphen, and N8 desmethyl Posiphen metabolite were determined for each of the three dose cohorts (Low Dose, Medium Dose, High Dose) by a protein precipitation extraction method using a high performance liquid chromatographic mass spectrometric detection method, with a linear weighted regression to determine the concentrations. | The confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. Plasma was collected at 0, 2, 4, 8, 12, 16, 20, and 24hrs during the confinement visit. |
| Fractional Synthesis Rate of Aβ40 in CSF Using the SILK™ Technique With Multiple Doses of Posiphen | The fractional synthesis rate (FSR) of Aβ40 was measured in the CSF using the SILK™ technique. FSR is a measure of the rate of Aβ synthesis in the brain. During 13C6-leucine infusion, 13C6-leucine is incorporated into newly synthesized proteins throughout the body, including the brain, in proportion to the available 13C6-leucine. This FSR is calculated as the rate of change of the ratio of 13C6-leucine-labeled Aβ proteins to unlabeled Aβ proteins in the lumbar CSF between 6 to 16 hours, normalized to the ratio of labeled to unlabeled leucine amino acid in plasma. It is reported as a fraction of 13C6-leucine-labeled to unlabeled Aβ proteins per hour. The ratio of Aβ in CSF containing 13C6-leucine to that containing unlabeled leucine is measured using mass spectrometry. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of CSF Catheter Study With SILK™ Technology to Evaluate Rates of Enrollment | Feasibility of CSF Catheter Study with SILK™ Technology was determined by comparing the total number of participants enrolled, randomized and treated with study drug in the trial to the total number of participants who completed the CSF Catheter Study across all participating sites. | Up to 25 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Alzheimer's Disease Research Center | La Jolla | California | 92037 | United States | ||
| IU Health Partners, Adult Neurology Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38970127 | Derived | Galasko D, Farlow MR, Lucey BP, Honig LS, Elbert D, Bateman R, Momper J, Thomas RG, Rissman RA, Pa J, Aslanyan V, Balasubramanian A, West T, Maccecchini M, Feldman HH. A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with early Alzheimer's Disease. Alzheimers Res Ther. 2024 Jul 5;16(1):151. doi: 10.1186/s13195-024-01490-z. | |
| 38562783 |
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Data from this research will be shared with other researchers pursuant to the 02/26/2003 "NIH Final Statement on Sharing Research Data". The ADCS through its Data and Sample Sharing Committee (DSSC) will receive requests for sample and data sharing. The ADCS grants access to de-identified data to qualified scientists who complete the request process and agree to conditions in an ADCS/UCSD Data Use Agreement (DUA) and the ADCS Publications Policy. After approval and receipt of the fully executed DUA, applicants are authorized to acquire data. Non-compliance with the DUA, including the requirement to provide requested updates will jeopardize further access to data. The same process and Committee reviews and approves biosample requests. If a request for biosample sharing is approved, a Material Transfer Agreement (MTA) will be negotiated between UCSD/ADCS and the requesting researcher or organization.
01 August 2023
Data requestors must complete an ADCS Data and Sample Sharing request form which will be reviewed by the ADCS DSSC. Upon approval, requestors must complete a Data Use Agreement (DUA) prior to accessing the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule |
| FG001 | Medium Dose | The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule |
| FG002 | High Dose | The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule |
| FG003 | Placebo | The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days. Placebo: oral solid dosage form capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule |
| BG001 | Medium Dose |
| 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 |
| 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 | Safety and Tolerability of Multiple Ascending Doses of Posiphen: Reports of Adverse Events or Study Discontinuations | Number of adverse events or study discontinuations, broken down by dose arm (i.e. Low vs. Medium vs. High vs. Placebo), and further broken down by relatedness to Posiphen (Definitely Related, Probably Related, Possibly Related, Unlikely Related, Unrelated) | Posted | Number | events | Up to 25 days |
|
From Randomization through Study Day 25.
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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 | Low Dose | The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| agitation | Psychiatric disorders | MedDRA version 18.00 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Feldman MDCM, FRCP(C) | Alzheimer's Disease Cooperative Study | 858-246-1347 | hhfeldman@health.ucsd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 23, 2021 | Jul 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2022 | Jul 15, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2021 | Feb 26, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C092280 | phenserine |
Not provided
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Not provided
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| Placebo | Drug | oral solid dosage form capsule |
|
| The confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. CSF was collected between 6 and 16hrs during the confinement visit. |
| Feasibility of CSF Catheter Study With SILK™ Technology to Evaluate %CSF Samples With Enough Volume for Testing | The % of cerebrospinal fluid samples with sufficient volume for testing will be determined across study participants during the SILK sampling procedure | Up to 25 days |
| Feasibility of CSF Catheter Study With SILK™ Technology to Evaluate Research Satisfaction | Research satisfaction will be evaluated by qualitative response to 14 questions asked to participants about their experience with the study procedures. Responses will be grouped and reported by common themes | Up to 25 days |
| Pharmacodynamic and PK-PD Effects on CSF Alzheimer's Disease Biomarkers | Aβ38, Aβ40, Aβ42, sAPPα, sAPPβ, and T-Tau were sampled at Screening and at the start of the confinement visit. Results of these measures were reported as a least square means, calculated as the change between the measured values at the start of the confinement visit and Screening in ng/mL. | CSF was sampled at Screening and at the start of the confinement visit, which occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. |
| Assessment of Mental Status Effects | The short-term effects of Posiphen on mental status will be measured using the Mini-Mental State Examination (MMSE). The MMSE is a brief, global cognitive measure that includes orientation, memory, attention, concentration, naming, writing, repetition, comprehension, and construction. The total score ranges from 0 (worst) to 30 (best performance). Results of the MMSE for this trial were reported as a raw change score, calculated as the change between the total scores at two evaluation time points (Baseline, Pre-Confinement Visit) and where negative values are worse and positive values are better. | MMSE was administered at Baseline and at the Pre-Confinement Visit 1-3 days prior to the Confinement Visit. This confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. |
| Assessment of Neuropsychiatric Effects | The Neuropsychiatric Inventory (NPI) was used to measure the frequency and severity of neuropsychiatric symptoms. On this scale frequency ratings range from 0 (no symptoms) to 4 (very frequently, once or more per day or continuously). Severity ratings range from 0 (no severity) to 3 (severe). The score for each of 12 symptoms measured in the scale is the product of severity and frequency within that symptom. The total score for the NPI is the sum of all 12 symptom item scores, for a highest possible total score of 144 in individuals with maximal symptoms, and a lowest possible total score of zero (0) in fully asymptomatic individuals. Lower scores are better and higher scores indicate more neuropsychiatric symptoms. Results are calculated as the change between the total scores at two evaluation time points (Baseline, Pre-Confinement Visit) with negative scores being better and positive scores being worse. | NPI was administered at Baseline and at the Pre-Confinement Visit 1-3 days prior to the Confinement Visit. This confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. |
| Assessment of Cognitive Effects | The short-term effects of Posiphen on cognition were measured using the The Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12). The ADAS-Cog is a structured scale that evaluates memory (word recall, word recognition), reasoning, language (naming, comprehension), orientation, ideational praxis and constructional praxis. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Total ADAS-Cog12 scores can range from 0 to 80, with lower scores being better and higher scores being worse. Results of the ADAS-Cog12 for this trial are reported as a raw change score, calculated as the change between the total scores at two evaluation time points (Baseline, Pre-Confinement Visit) with negative scores being better and positive scores being worse. | ADAS-Cog12 was administered at Baseline and at the Pre-Confinement Visit 1-3 days prior to the Confinement Visit. This confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, also allowing a +/- 2-day visit window. |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Washington University Sleep Medicine Center | Brentwood | Missouri | 63144 | United States |
| Columbia University Medical Center Sergievsky Center Taub Institute | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Derived |
| Galasko D, Farlow MR, Lucey BP, Honig LS, Elbert D, Bateman R, Momper J, Thomas R, Rissman RA, Pa J, Aslanyan V, Balasubramanian A, West T, Maccecchini M, Feldman HH. A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with Early Alzheimer's Disease. medRxiv [Preprint]. 2024 Mar 22:2024.03.20.24304638. doi: 10.1101/2024.03.20.24304638. |
The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days.
Posiphen: oral solid dosage form capsule
| BG002 | High Dose | The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule |
| BG003 | Placebo | The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days. Placebo: oral solid dosage form capsule |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | High Dose | The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule |
| OG003 | Placebo | The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days. Placebo: oral solid dosage form capsule |
|
|
| Primary | The Levels of Posiphen and Its Metabolites Will be Determined in Plasma | Mean plasma concentrations of levels of posiphen tartrate, N1 desmethyl posiphen, and N8 desmethyl Posiphen metabolite were determined for each of the three dose cohorts (Low Dose, Medium Dose, High Dose) by a protein precipitation extraction method using a high performance liquid chromatographic mass spectrometric detection method, with a linear weighted regression to determine their concentrations. | Participants in the Placebo Arm/Group were not given study drug. Therefore, measurements of study drug, Posiphen, and its metabolites were not performed on the Placebo Arm/Group. | Posted | Mean | Standard Deviation | ng/mL | The confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. Plasma was collected at 0, 2, 4, 8, 12, 16, 20, and 24hrs during the confinement visit. |
|
|
|
| Primary | The Levels of Posiphen and Its Metabolites Will be Determined in Cerebrospinal Fluid (CSF) | Mean CSF concentrations of levels of posiphen tartrate, N1 desmethyl posiphen, and N8 desmethyl Posiphen metabolite were determined for each of the three dose cohorts (Low Dose, Medium Dose, High Dose) by a protein precipitation extraction method using a high performance liquid chromatographic mass spectrometric detection method, with a linear weighted regression to determine the concentrations. | Participants in the Placebo Arm/Group were not given study drug. Therefore, measurements of study drug, Posiphen, and its metabolites were not performed on the Placebo Arm/Group. | Posted | Mean | Standard Deviation | ng/mL | The confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. Plasma was collected at 0, 2, 4, 8, 12, 16, 20, and 24hrs during the confinement visit. |
|
|
|
| Primary | Fractional Synthesis Rate of Aβ40 in CSF Using the SILK™ Technique With Multiple Doses of Posiphen | The fractional synthesis rate (FSR) of Aβ40 was measured in the CSF using the SILK™ technique. FSR is a measure of the rate of Aβ synthesis in the brain. During 13C6-leucine infusion, 13C6-leucine is incorporated into newly synthesized proteins throughout the body, including the brain, in proportion to the available 13C6-leucine. This FSR is calculated as the rate of change of the ratio of 13C6-leucine-labeled Aβ proteins to unlabeled Aβ proteins in the lumbar CSF between 6 to 16 hours, normalized to the ratio of labeled to unlabeled leucine amino acid in plasma. It is reported as a fraction of 13C6-leucine-labeled to unlabeled Aβ proteins per hour. The ratio of Aβ in CSF containing 13C6-leucine to that containing unlabeled leucine is measured using mass spectrometry. | 15 participants completed the Confinement visit and had sufficient samples to enable this analysis | Posted | Mean | Full Range | fraction labeled:unlabeled Aβ40 per hr | The confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. CSF was collected between 6 and 16hrs during the confinement visit. |
|
|
|
| Secondary | Feasibility of CSF Catheter Study With SILK™ Technology to Evaluate Rates of Enrollment | Feasibility of CSF Catheter Study with SILK™ Technology was determined by comparing the total number of participants enrolled, randomized and treated with study drug in the trial to the total number of participants who completed the CSF Catheter Study across all participating sites. | Overall number of participants completing the protocol | Posted | Count of Participants | Participants | Up to 25 days |
|
|
|
| Secondary | Feasibility of CSF Catheter Study With SILK™ Technology to Evaluate %CSF Samples With Enough Volume for Testing | The % of cerebrospinal fluid samples with sufficient volume for testing will be determined across study participants during the SILK sampling procedure | The % of CSF samples with sufficient volume for testing will be determined across study participants during the SILK sampling procedure | Posted | Number | percentage of CSF samples | Up to 25 days |
|
|
|
| Secondary | Feasibility of CSF Catheter Study With SILK™ Technology to Evaluate Research Satisfaction | Research satisfaction will be evaluated by qualitative response to 14 questions asked to participants about their experience with the study procedures. Responses will be grouped and reported by common themes | Posted | Number | percentage of participants | Up to 25 days |
|
|
|
| Secondary | Pharmacodynamic and PK-PD Effects on CSF Alzheimer's Disease Biomarkers | Aβ38, Aβ40, Aβ42, sAPPα, sAPPβ, and T-Tau were sampled at Screening and at the start of the confinement visit. Results of these measures were reported as a least square means, calculated as the change between the measured values at the start of the confinement visit and Screening in ng/mL. | Posted | Least Squares Mean | Standard Error | ng/mL | CSF was sampled at Screening and at the start of the confinement visit, which occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. |
|
|
|
| Secondary | Assessment of Mental Status Effects | The short-term effects of Posiphen on mental status will be measured using the Mini-Mental State Examination (MMSE). The MMSE is a brief, global cognitive measure that includes orientation, memory, attention, concentration, naming, writing, repetition, comprehension, and construction. The total score ranges from 0 (worst) to 30 (best performance). Results of the MMSE for this trial were reported as a raw change score, calculated as the change between the total scores at two evaluation time points (Baseline, Pre-Confinement Visit) and where negative values are worse and positive values are better. | Posted | Mean | Standard Deviation | score on a scale | MMSE was administered at Baseline and at the Pre-Confinement Visit 1-3 days prior to the Confinement Visit. This confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. |
|
|
|
| Secondary | Assessment of Neuropsychiatric Effects | The Neuropsychiatric Inventory (NPI) was used to measure the frequency and severity of neuropsychiatric symptoms. On this scale frequency ratings range from 0 (no symptoms) to 4 (very frequently, once or more per day or continuously). Severity ratings range from 0 (no severity) to 3 (severe). The score for each of 12 symptoms measured in the scale is the product of severity and frequency within that symptom. The total score for the NPI is the sum of all 12 symptom item scores, for a highest possible total score of 144 in individuals with maximal symptoms, and a lowest possible total score of zero (0) in fully asymptomatic individuals. Lower scores are better and higher scores indicate more neuropsychiatric symptoms. Results are calculated as the change between the total scores at two evaluation time points (Baseline, Pre-Confinement Visit) with negative scores being better and positive scores being worse. | Posted | Mean | Standard Deviation | score on a scale | NPI was administered at Baseline and at the Pre-Confinement Visit 1-3 days prior to the Confinement Visit. This confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, while also allowing a +/- 2-day visit window. |
|
|
|
| Secondary | Assessment of Cognitive Effects | The short-term effects of Posiphen on cognition were measured using the The Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12). The ADAS-Cog is a structured scale that evaluates memory (word recall, word recognition), reasoning, language (naming, comprehension), orientation, ideational praxis and constructional praxis. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Total ADAS-Cog12 scores can range from 0 to 80, with lower scores being better and higher scores being worse. Results of the ADAS-Cog12 for this trial are reported as a raw change score, calculated as the change between the total scores at two evaluation time points (Baseline, Pre-Confinement Visit) with negative scores being better and positive scores being worse. | Posted | Mean | Standard Deviation | score on a scale | ADAS-Cog12 was administered at Baseline and at the Pre-Confinement Visit 1-3 days prior to the Confinement Visit. This confinement visit occurred following 21-23 days of treatment with either Posiphen or placebo, also allowing a +/- 2-day visit window. |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Medium Dose | The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule | 0 | 5 | 0 | 5 | 4 | 5 |
| EG002 | High Dose | The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Placebo | The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days. Placebo: oral solid dosage form capsule | 0 | 7 | 0 | 7 | 4 | 7 |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | Systematic Assessment |
|
| catheter site swelling | Injury, poisoning and procedural complications | MedDRA version 18.00 | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.00 | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA version 18.00 | Systematic Assessment |
|
| fatigue | General disorders | MedDRA version 18.00 | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA version 18.00 | Systematic Assessment |
|
| injection site pain | Injury, poisoning and procedural complications | MedDRA version 18.00 | Systematic Assessment |
|
| injection site swelling | Injury, poisoning and procedural complications | MedDRA version 18.00 | Systematic Assessment |
|
| lethargy | General disorders | MedDRA version 18.00 | Systematic Assessment |
|
| medical device complication | Gastrointestinal disorders | MedDRA version 18.00 | Systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | Systematic Assessment |
|
| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.00 | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA version 18.00 | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | Systematic Assessment |
|
| pain | General disorders | MedDRA version 18.00 | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | Systematic Assessment |
|
| pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | Systematic Assessment |
|
| paraesthesia | Nervous system disorders | MedDRA version 18.00 | Systematic Assessment |
|
| post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA version 18.00 | Systematic Assessment |
|
| productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.00 | Systematic Assessment |
|
| rhinitis | Infections and infestations | MedDRA version 18.00 | Systematic Assessment |
|
| sunburn | Injury, poisoning and procedural complications | MedDRA version 18.00 | Systematic Assessment |
|
| traumatic lumbar puncture | Injury, poisoning and procedural complications | MedDRA version 18.00 | Systematic Assessment |
|
| tremor | Nervous system disorders | MedDRA version 18.00 | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA version 18.00 | Systematic Assessment |
|
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
|
| N8 metabolite |
|
|
| N8 metabolite |
|
|
| Reported "Yes, definitely" they would choose to participate again. |
|
| Reported "Volunteering" as what they liked best about the study. |
|
| Reported "Time Commitment" as what they liked least about the study. |
|
| Reported "Yes", the 36 hour catheter procedure was done. |
|
| Reported "No" adverse events were associated with the 36hr catheter procedure. |
|
| Reported "Excellent" as the quality of the 36hr catheter procedure and attention they received. |
|
| Reported the catheter procedure was "almost all of what I expected." |
|
| Reported they liked best was "participating in cutting edge research and interacting with the team". |
|
| Reported "Other" as what they liked least about the 36hr catheter procedure. |
|
| Reported "Other" as what they would change about the 36hr catheter procedure. |
|
| Reported they would change the number of visits. |
|
| Aβ42 |
|
| sAPPα |
|
| sAPPβ |
|
| Total Tau |
|