Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000937-11 | EudraCT Number | ||
| MK-7622-012 | Other Identifier | Merck Protocol Number |
Not provided
Not provided
Not provided
Stage 1 interim analysis of efficacy met the criteria for early trial termination (futility). The trial was terminated at Stage 1; did not proceed to Stage 2.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this multicenter trial is to assess the efficacy and safety of MK-7622 compared with placebo as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for the symptomatic treatment of participants with mild to moderate Alzheimer's Disease (AD). The trial consists of two stages: Stage 1 and Stage 2. In Stage 1, participants will be randomized to receive either placebo or MK-7622 45 mg once daily. In Stage 2, participants will be randomized to receive either placebo or MK-7622 (dose: 5, 15 or 45 mg once daily). Participants will be enrolled in only one stage; the duration of each stage is approximately 26 weeks. Interim analyses will be performed in both Stage 1 and Stage 2 to determine whether the trial should continue. The primary study hypotheses are the following: Stage 1 - MK-7622 45 mg once daily is superior to placebo with respect to improving cognition in participants with mild to moderate AD as assessed by mean change from baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Week 12; Stage 2 - At least one of the top two doses of MK-7622 (15 mg once daily, 45 mg once daily) is superior to placebo with respect to improving cognition in participants with mild to moderate AD as assessed by mean change from baseline in ADAS-Cog11 at Week 12.
If the double-blind treatment dose is not tolerated during the first 2 weeks, the participant will be discontinued. After the first 2 weeks, if the dose is not tolerated, the regimen may be modified according to a defined algorithm. Specifically, the participant will begin administration of a reduced dose for up to 2 weeks, followed by a re-challenge at the original dose only if tolerability issues diminish or resolve at the reduced dose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7622 High Dose - 45 mg (Stage 1) | Experimental | Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. |
|
| Placebo (Stage 1) | Placebo Comparator | Matching placebo to MK-7622 capsule once daily, taken orally. |
|
| MK-7622 Low Dose - 5 mg (Stage 2) | Experimental | Single 5 mg MK-7622 capsule once daily, taken orally. |
|
| MK-7622 Mid Dose - 15 mg (Stage 2) | Experimental | Single 15 mg MK-7622 capsule once daily, taken orally. |
|
| MK-7622 High Dose - 45 mg (Stage 2) | Experimental | Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7622 | Drug | MK-7622 capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo) | Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score. | Baseline and week 12 |
| Change From Baseline in ADAS-Cog11 Score at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo) | Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score. | Baseline and week 12 |
| Number of Participants Experiencing an Adverse Event (AE) | The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) at Week 24 (Combining Stage 1 and 2, MK-7622 45 mg Versus Placebo) | Mean change from baseline at week 24 was assessed for ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with potential total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29955661 | Result | Voss T, Li J, Cummings J, Farlow M, Assaid C, Froman S, Leibensperger H, Snow-Adami L, McMahon KB, Egan M, Michelson D. Randomized, controlled, proof-of-concept trial of MK-7622 in Alzheimer's disease. Alzheimers Dement (N Y). 2018 Apr 26;4:173-181. doi: 10.1016/j.trci.2018.03.004. eCollection 2018. |
Not provided
Not provided
Not provided
Not provided
Not provided
Stage 1 interim analysis met the prespecified futility threshold for the primary efficacy endpoint, satisfying the clinical criteria for early trial termination (futility). As a result, the trial was terminated at Stage 1; did not proceed to Stage 2.
In stage 1: 1 randomized participant received no study medication (MK-7622 High Dose-45 mg arm).
Number of Participants Screened: 505 Number of Participants Randomized: 240
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MK-7622 High Dose - 45 mg (Stage 1) | Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. |
| FG001 | Placebo (Stage 1) | Matching placebo to MK-7622 capsule once daily, taken orally. |
| FG002 | MK-7622 Low Dose - 5 mg (Stage 2) | Single 5 mg MK-7622 capsule once daily, taken orally. |
| FG003 | MK-7622 Mid Dose - 15 mg (Stage 2) | Single 15 mg MK-7622 capsule once daily, taken orally. |
| FG004 | MK-7622 High Dose - 45 mg (Stage 2) | Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. |
| FG005 | Placebo (Stage 2) | Matching placebo to MK-7622 capsule once daily, taken orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes only participants in Stage 1 who were both randomized (i.e. started) and treated.
In stage 1:
MK-7622 High Dose - 45 mg: of the randomized participants (n=120), all but 1 randomized participant received study treatment (n=119).
Placebo: Of the randomized participants (n=120), all received study treatment (n=120).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK-7622 High Dose - 45 mg (Stage 1) | Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. |
| BG001 | Placebo (Stage 1) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo) | Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score. | All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week ADAS-Cog11 assessment. | Posted | Mean | Standard Error | Score on a Scale | Baseline and week 12 |
|
Up to 26 weeks
Not provided
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 | MK-7622 High Dose - 45 mg (Stage 1) | Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
Stage 1 Interim analysis of efficacy met the clinical criteria for early trial termination (futility). As a result, the trial was terminated at Stage 1 and did not proceed to Stage 2.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (Stage 2) | Placebo Comparator | Matching placebo to MK-7622 capsule once daily, taken orally. |
|
| Placebo | Drug | Matching placebo to MK-7622 capsule |
|
| AChEI | Drug | One of the following AChEIs, as prescribed by the participant's primary care physician: Donepezil: 10 mg total daily dose, administered orally Rivastigmine: 9.5 or 13.3 mg/24 hours, administered by transdermal patch; or 6-12 mg total daily dose administered orally Galantamine: 16-24 mg total daily dose, administered orally |
|
| Up to 26 weeks |
| Number of Participants Who Discontinued Study Drug Due to an AE | The number of participants discontinuing study drug due to an AE was assessed. | Up to 24 weeks |
| Baseline and week 24 |
| Change From Baseline in Composite Cognition Score-3 Domain (CCS-3D) at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo) | CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline. | Baseline and week 12 |
| Change From Baseline in CCS-3D at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo) | CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline. | Baseline and Week 12 |
| Lost to Follow-up |
|
| Non-compliance with Study Drug |
|
| Physician Decision |
|
| Protocol Violation |
|
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
Matching placebo to MK-7622 capsule once daily, taken orally. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score | ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score (range: 0-70). Higher total scores indicate greater cognitive impairment. | Includes only randomized participants receiving ≥1 dose of study medication, having a baseline ADAS-Cog11 assessment. | Mean | Standard Deviation | Score on a Scale |
|
| Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score | The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with potential total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. | Includes only randomized participants receiving ≥1 dose of study medication, having a baseline ADCS-ADL assessment. | Mean | Standard Deviation | Score on a Scale |
|
| Composite Cognition Score-3 Domain (CCS-3D) | CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. | Includes only randomized participants receiving ≥1 dose of study medication, having a baseline CCS-3D assessment. | Mean | Standard Deviation | z-score |
|
| Title |
|---|
| Description |
|---|
| OG000 | MK-7622 High Dose - 45 mg (Stage 1) | Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. |
| OG001 | Placebo (Stage 1) | Matching placebo to MK-7622 capsule once daily, taken orally. |
|
|
|
| Primary | Change From Baseline in ADAS-Cog11 Score at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo) | Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score. | Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 - 15 mg, or MK-7622 - 45 mg, having either a baseline or 12-week ADAS-Cog11 assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure. | Posted | Baseline and week 12 |
|
|
| Primary | Number of Participants Experiencing an Adverse Event (AE) | The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE. | All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Number of Participants Who Discontinued Study Drug Due to an AE | The number of participants discontinuing study drug due to an AE was assessed. | All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
|
| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) at Week 24 (Combining Stage 1 and 2, MK-7622 45 mg Versus Placebo) | Mean change from baseline at week 24 was assessed for ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with potential total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score. | Per protocol, analysis population was to include all randomized participants (pooled across Stages 1 and 2) receiving ≥1 dose of placebo or MK-7622 - 45 mg, having either a baseline or 24-week ADCS-ADL assessment. As the study was terminated before Stage 2 enrollment, only participants in Stage 1 were analyzed. | Posted | Mean | Standard Error | Score on a Scale | Baseline and week 24 |
|
|
|
|
| Secondary | Change From Baseline in Composite Cognition Score-3 Domain (CCS-3D) at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo) | CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline. | All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week CCS-3D assessment. | Posted | Mean | Standard Error | z-score | Baseline and week 12 |
|
|
|
|
| Secondary | Change From Baseline in CCS-3D at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo) | CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline. | Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 - 15 mg, or MK-7622 - 45 mg, having either a baseline or 12-week CCS-3D assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure. | Posted | Baseline and Week 12 |
|
|
| 9 |
| 119 |
| 42 |
| 119 |
| EG001 | Placebo (Stage 1) | Matching placebo to MK-7622 capsule once daily, taken orally. | 4 | 120 | 20 | 120 |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |