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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_534 |
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The purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK0249 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0249 | Drug | MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. | The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance. | Baseline and Week 4 |
| Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score | The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Week 4 Change From Baseline in Cognition Summary Score (CSS) | The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline: Short CNTB Summary Score. | The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22272611 | Result | Egan M, Yaari R, Liu L, Ryan M, Peng Y, Lines C, Michelson D. Pilot randomized controlled study of a histamine receptor inverse agonist in the symptomatic treatment of AD. Curr Alzheimer Res. 2012 May;9(4):481-90. doi: 10.2174/156720512800492530. |
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At Visit 1, patients were assessed using the protocol inclusion and exclusion criteria, then, if deemed eligible, patients were randomized at Visit 3.
First Patient Dosed: 13 JAN 2007; Last Patient Last Treatment: 14 AUG 2008. 15 U.S. outpatient centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0249 (5 mg) | Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd). |
| FG001 | Placebo | Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK0249 (5 mg) | Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd). |
| BG001 | Placebo | Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd). |
| 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 | Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. | The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance. | Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 4 |
|
Patients were assessed for AEs from Visit 2 (Day 0) Baseline through Visit 8 (Day 43) Post-Study Safety Visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK0249 (5 mg) | Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| 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 |
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| ID | Term |
|---|---|
| C574738 | MK-0249 |
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| Comparator: Placebo (unspecified) |
| Drug |
MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period |
|
| Baseline and Week 4 |
| Baseline |
| Baseline: ADAS-Cog Total Score | The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance. | Baseline |
| Baseline: Cognition Summary Score (CSS) | The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance. | Baseline |
| Withdrawal by Subject |
|
| sponsor decision (abnormal ECG @ screen) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd). |
| OG001 | Placebo | Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd). |
|
|
|
| Secondary | Week 4 Change From Baseline in Cognition Summary Score (CSS) | The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance. | Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 4 |
|
|
|
|
| Primary | Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score | The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance. | Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 4 |
|
|
|
|
| Other Pre-specified | Baseline: Short CNTB Summary Score. | The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance. | Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Other Pre-specified | Baseline: ADAS-Cog Total Score | The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance. | Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Other Pre-specified | Baseline: Cognition Summary Score (CSS) | The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance. | Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 3 |
| 73 |
| 29 |
| 73 |
| EG001 | Placebo | Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd). | 1 | 70 | 9 | 70 |
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |