Clinical trial NCT01089582: Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets
Official title: Quality Of Life Assessment In AD Patients Receiving Aricept Tablets (Donepezil Hydrochloride)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: non-interventional
mild to moderate Alzheimer's
ARICEPT.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mild to moderate dementia of the Alzheimer's type

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alzheimer's Disease

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
timeFrame: Baseline, Week 12.
measure: Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
timeFrame: Baseline, Week 12.
measure: 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
timeFrame: Baseline, Week 12.
measure: 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
timeFrame: Baseline, Week 12.
Secondary outcomes:
measure: Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
timeFrame: Baseline to Week 12.
measure: Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
timeFrame: Week 12.
measure: Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
timeFrame: Baseline to Week 12.
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis Dimokritio
state: Thrace
city: Arta
country: Greece
facility: General Hospital of Arta
city: Athens
country: Greece
facility: NIMITS (Geriatric Department)
city: Athens
country: Greece
facility: NIMITS Geriatric Department
city: Athens
country: Greece
facility: General Hospital of Athens Laikon Dementia Department
city: Athens
country: Greece
facility: Naval Hospital, Dementia Department
city: Athens
country: Greece
facility: General State Hospital "G. Genimatas", Neurology Department
city: Athens
country: Greece
facility: ATTIKON University General Hospital (Dementia Department)
city: Athens
country: Greece
facility: Psychiatric Hospital of Attica Dromokaiteio, Psychiatric Department
city: Athens
country: Greece
facility: 1st IKA Hospital Neurology Clinic
city: Athens
country: Greece
facility: Sismanogleio Psychiatric Clinic
city: Athens
country: Greece
facility: HYGEIA Diagnostic & Therapeutic Center of Athens Internal Medicine Department
city: Athens
country: Greece
facility: 251 General air force hospital
city: Chaidari
country: Greece
facility: Psychiatric Hospital, Psychogeriatric Clinic
city: Crete
country: Greece
facility: Venizeleio General Hospital
city: Crete
country: Greece
facility: Hospital of Chania
city: Giannitsa
country: Greece
facility: Hospital of Giannitsa
city: Ioannina
country: Greece
facility: University General Hospital
city: Ioannina
country: Greece
facility: General Hospital of Ioannina
city: Katerini
country: Greece
facility: Center of Psychiatric Health of Katerini
city: Kavala
country: Greece
facility: General Hospital Neurological Clinic
city: Patra
country: Greece
facility: Ag. Andreas
city: Thessaloniki
country: Greece
facility: A.H.E.P.A University General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: B´ IKA Panagia Hospital, Dementia Departments
city: Thessaloniki
country: Greece
facility: Papageorgiou hospital
city: Thessaloniki
country: Greece
facility: Psychiatric hospital, 1st Psychogeriatric Department
city: Thessaloniki
country: Greece
facility: Psychiatric Hospital of Thessaloniki, Psychiatric Department
city: Thessaloniki
country: Greece
facility: G. Papanikolaou Hospital 3rd Neurology Clinic
city: Tripoli
country: Greece
facility: Centre of Psychiatric Health
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: