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This study assessed the Hr QoL (Health related Quality of life) of subjects with mild to moderate AD, who received ARICEPT under usual clinical practice.
This non-interventional study enrolled patients with mild to moderate dementia of the Alzheimer's type, who have been prescribed treatment with ARICEPT under usual clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse. | Baseline, Week 12. |
| Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'. | Baseline, Week 12. |
| Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. | Baseline, Week 12. |
| Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. | Baseline, Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study. | Baseline to Week 12. |
| Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with mild to moderate dementia of the Alzheimer's type
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Alexandroupolis Dimokritio | Alexandroupoli | Thrace | 68100 | Greece | ||
| General Hospital of Arta |
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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 | ARICEPT | ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 12. |
| Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable. | Baseline to Week 12. |
| Arta |
| 47-100 |
| Greece |
| NIMITS (Geriatric Department) | Athens | 11-521 | Greece |
| NIMITS Geriatric Department | Athens | 11-521 | Greece |
| General Hospital of Athens Laikon Dementia Department | Athens | 11-527 | Greece |
| Naval Hospital, Dementia Department | Athens | 115-21 | Greece |
| General State Hospital "G. Genimatas", Neurology Department | Athens | 11527 | Greece |
| ATTIKON University General Hospital (Dementia Department) | Athens | 124-62 | Greece |
| Psychiatric Hospital of Attica Dromokaiteio, Psychiatric Department | Athens | 12461 | Greece |
| 1st IKA Hospital Neurology Clinic | Athens | 151 27 | Greece |
| Sismanogleio Psychiatric Clinic | Athens | 151-26 | Greece |
| HYGEIA Diagnostic & Therapeutic Center of Athens Internal Medicine Department | Athens | 15123 | Greece |
| 251 General air force hospital | Athens | Greece |
| Psychiatric Hospital, Psychogeriatric Clinic | Chaïdári | 124-22 | Greece |
| Venizeleio General Hospital | Crete | 710-01 | Greece |
| Hospital of Chania | Crete | 731-00 | Greece |
| Hospital of Giannitsa | Giannitsá | Greece |
| University General Hospital | Ioannina | 45-000 | Greece |
| General Hospital of Ioannina | Ioannina | 45-001 | Greece |
| Center of Psychiatric Health of Katerini | Katerini | 60-100 | Greece |
| General Hospital Neurological Clinic | Kavala | 652-01 | Greece |
| Ag. Andreas | Pátrai | 260-00 | Greece |
| A.H.E.P.A University General Hospital of Thessaloniki | Thessaloniki | 546 36 | Greece |
| B´ IKA Panagia Hospital, Dementia Departments | Thessaloniki | 551-32 | Greece |
| Papageorgiou hospital | Thessaloniki | 562-49 | Greece |
| Psychiatric hospital, 1st Psychogeriatric Department | Thessaloniki | 564-29 | Greece |
| Psychiatric Hospital of Thessaloniki, Psychiatric Department | Thessaloniki | 56429 | Greece |
| G. Papanikolaou Hospital 3rd Neurology Clinic | Thessaloniki | 57010 | Greece |
| Centre of Psychiatric Health | Tripoli | 221-00 | Greece |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARICEPT | ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Medical History | Participants were counted once per medical history but could be counted in more than one medical history. | Number | 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 | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse. | Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT. | Posted | Number | participants | Baseline, Week 12. |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'. | FAS. | Posted | Number | participants | Baseline, Week 12. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. | FAS; (n)=number of participants evaluable at baseline and Week 12. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. | FAS; (n)=number of participants evaluable at baseline and Week 12. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study. | FAS. Starting dose of ARICEPT was not summarized. | Posted | Number | participants | Baseline to Week 12. |
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| Secondary | Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT | FAS. | Posted | Number | participants | Week 12. |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable. | FAS. | Posted | Number | participants | Baseline to Week 12. |
|
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The same event may appear as both an AE and a 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 | ARICEPT | ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD. | 2 | 603 | 39 | 603 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Behavioural and psychiatric symptoms of dementia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Delusional disorder, unspecified type | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysthymic disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Illusion | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Title | Measurements |
|---|---|
|
| Unspecified |
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| Unspecified |
|
| Aortic valve incompetence |
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| Arrhythmia |
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| Atrial fibrillation |
|
| Cardiac failure |
|
| Coronary artery disease |
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| Thalassaemia trait |
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| Vertigo |
|
| Goitre |
|
| Hyperthyroidism |
|
| Hypothyroidism |
|
| Cataract |
|
| Eye disorder |
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| Glaucoma |
|
| Colitis |
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| Diverticulum |
|
| Diverticulum intestinal |
|
| Gastrooesophageal reflux disease |
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| Pancreatitis chronic |
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| Necrosis |
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| Sarcoidosis |
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| Erysipelas |
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| Panencephalitis |
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| Traumatic brain injury |
|
| Vitamin B12 decreased |
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| Diabetes mellitus |
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| Dyslipidaemia |
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| Hypercholesterolaemia |
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| Hyperlipidaemia |
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| Hyperuricaemia |
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| Arthritis |
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| Arthropathy |
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| Musculoskeletal pain |
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| Osteoarthritis |
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| Osteoporosis |
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| Rheumatoid arthritis |
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| Haemangioma |
|
| Prostate cancer |
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| Carotid artery disease |
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| Cerebral ischaemia |
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| Cerebrovascular accident |
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| Dementia |
|
| Diabetic neuropathy |
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| Dystonia |
|
| Epilepsy |
|
| Extrapyramidal disorder |
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| Headache |
|
| Migraine |
|
| Motor neurone disease |
|
| Multiple sclerosis |
|
| Myasthenia gravis |
|
| Parkinson's disease |
|
| Polyneuropathy |
|
| Sciatica |
|
| Tremor |
|
| Abnormal behaviour |
|
| Anxiety disorder |
|
| Bipolar disorder |
|
| Depression |
|
| Neurosis |
|
| Personality change due to a general medical condit |
|
| Phobia |
|
| Psychotic disorder |
|
| Psychotic disorder due to a general medical condit |
|
| Schizophrenia |
|
| Schizophrenia, paranoid type |
|
| Sleep disorder |
|
| Stress |
|
| Glomerulonephritis |
|
| Incontinence |
|
| Renal failure |
|
| Renal failure chronic |
|
| Urinary incontinence |
|
| Urinary retention |
|
| Benign prostatic hyperplasia |
|
| Prostatic disorder |
|
| Prostatomegaly |
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| Asthma |
|
| Chronic obstructive pulmonary disease |
|
| Lichen sclerosus |
|
| Cardiac operation |
|
| Cardiac pacemaker insertion |
|
| Oesophageal operation |
|
| Arterial disorder |
|
| Hypertension |
|
| Temporal arteritis |
|
| Varicose vein |
|
| Venous insufficiency |
|
| Title | Measurements |
|---|---|
|
| Much improved |
|
| Minimally improved |
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| No change |
|
| Minimally worse |
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| Much worse |
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| Very much worse |
|
|
|
|
|
|
|
|
| Categories |
|---|
| Missing |
| |||||
| 5 mg |
| |||||
| 10 mg |
| |||||
| greater than 10 mg |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Missing |
| |||||
| Very good |
| |||||
| Good |
| |||||
| Adequate |
| |||||
| Unstatisfactory |
| |||||
| Unevaluable |
|