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The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week length of the study aims to collect data from a large number of patients (n= 400) on the safety and efficacy at the usual dosage of the product providing an overview of Aricept® Evess profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aricept® Evess | Drug | 5 mg film-coated orodispersible tablets, 10 mg film-coated orodispersible tablets. Treatment may be started with 5 mg donepezil/ day (once-a-day dosing) and after four weeks can be titrated to 10 mg/day (once-a-day dosing). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MMSE Total | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Tolerability | Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor | Week 24 |
| Number of Participants Receiving Other Medications | Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied. |
Inclusion Criteria:
Exclusion Criteria:
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The patients will be selected from those addressing psychiatrists on an outpatient bases, male / female, older than 50 years, being diagnosed with Alzheimer's Disease and Vascular Dementia, with MMSE score between 12 - 24.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bacau | Jud. Bacau | 600114 | Romania | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil | 5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil | 5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline. | Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data. | Posted | Mean | Standard Error | Scores on a scale | Baseline and Week 24 |
|
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The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Donepezil | 5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
FAQ Change from baseline not analyzed, a note to file was issued stating it was removed from protocol but erroneously remained in statistical analysis section. Patient Domain of Benefit, Week 24 LOCF not analyzed; endpoint only collected at Week 24.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline, Week 8, 16, and 24 |
| Change From Baseline in Functional Activity Questionnaire (FAQ) | Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores. | Baseline and Week 24 |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Week 8 |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Week 16 |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Week 24 |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Week 24 |
| Number of Participants in Each Patient Domain of Benefit | Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no'). | Week 24 |
| Baseline and Week 24 |
| Cluj-Napoca |
| Jud. Cluj |
| 400001 |
| Romania |
| Pfizer Investigational Site | Cluj-Napoca | Jud. Cluj | Romania |
| Pfizer Investigational Site | Constanța | Jud. Constanta | Romania |
| Pfizer Investigational Site | Craiova | Jud. Dolj | Romania |
| Pfizer Investigational Site | Iași | Jud. Iasi | 700282 | Romania |
| Pfizer Investigational Site | Ploieşti | Jud. Prahova | Romania |
| Pfizer Investigational Site | Timișoara | Jud. Timis | Romania |
| Pfizer Investigational Site | Bucharest | 041902 | Romania |
| Pfizer Investigational Site | Bucharest | 061301 | Romania |
| Pfizer Investigational Site | Bucharest | Romania |
| Pfizer Investigational Site | Iași | 700282 | Romania |
| No longer willing to participant in stud |
|
| Other |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change From Baseline in MMSE Total | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE. | FAS. N=number of participants with evaluable data. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 8, 16, and 24 |
|
|
|
|
| Secondary | Change From Baseline in Functional Activity Questionnaire (FAQ) | Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores. | FAS. Data not analyzed | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 24 |
|
|
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | FAS. N=number of participants with evaluable data. | Posted | Number | Participants | Week 8 |
|
|
|
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | FAS. N=number of participants with evaluable data. | Posted | Number | Participants | Week 16 |
|
|
|
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | FAS. N=number of participants with evaluable data. | Posted | Number | Participants | Week 24 |
|
|
|
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | FAS; LOCF. N=number of participants with evaluable data. | Posted | Number | Participants | Week 24 |
|
|
|
| Secondary | Number of Participants in Each Patient Domain of Benefit | Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no'). | Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24. | Posted | Number | Participants | Week 24 |
|
|
|
| Other Pre-specified | Number of Participants With Treatment Tolerability | Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor | Safety population; N=number of particpants with evaluable data. | Posted | Number | Participants | Week 24 |
|
|
|
| Other Pre-specified | Number of Participants Receiving Other Medications | Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied. | Safety population | Posted | Number | Participants | Baseline and Week 24 |
|
|
|
| 12 |
| 370 |
| 52 |
| 370 |
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Withdrawal syndrome | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Impulse-control disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| Mean Difference (Final Values) |
| 1.56 |
| 2-Sided |
| 95 |
| 1.32 |
| 1.80 |
LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week. |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 1.97 | 2-Sided | 95 | 1.69 | 2.25 | LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week. | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
|
| Poor |
|