Alzheimer DiseasePhase 3NCT00630851
A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
A Phase 3 study testing Donepezil (Aricept) in people with Alzheimer Disease, run by Pfizer at 53 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donepezil (Aricept)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 53 sitesin 2 countries
- Study dates
- Oct 2002to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable or possible Alzheimer's disease
- Living in skilled nursing home
Who cannot join
- Other types of dementia or psychiatric or neurologic disorders
- Musculoskeletal disease
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
Sweden52 sites
Pfizer Investigational Site
Åkersberga, 184 33 AKERSBERGA
Pfizer Investigational Site
Alunda, 747 30
Pfizer Investigational Site
Aneby, 578 21
Pfizer Investigational Site
Årsta, 120 54
Pfizer Investigational Site
Avesta, 774 82
Pfizer Investigational Site
Bengtsfors, 666 30
Pfizer Investigational Site
Bergsjö, 820 70
Pfizer Investigational Site
Boden, 931 64
Pfizer Investigational Site
Borlänge, 781 27
Pfizer Investigational Site
Degerfors, 693 22
Pfizer Investigational Site
Eskilstuna, 631 88
Pfizer Investigational Site
Eskilstuna, 632 23
Pfizer Investigational Site
Fritsla, Sweden, 510 29
Pfizer Investigational Site
Gislaved, 332 30
Pfizer Investigational Site
Gothenburg, 412 75
Pfizer Investigational Site
Gullspång, 547 31
Pfizer Investigational Site
Gustavsberg, 134 30
Pfizer Investigational Site
Hedemora, 776 28
Pfizer Investigational Site
Helsingborg, 254 43
Pfizer Investigational Site
Ingelstad, 360 44
Pfizer Investigational Site
Jönköping, 553 16
Pfizer Investigational Site
Kalix, 952 82
Pfizer Investigational Site
Karlstad, 656 37
Pfizer Investigational Site
Katrineholm, 641 47
Pfizer Investigational Site
Kristinehamn, 681 29
Pfizer Investigational Site
Lidköping, 531 85
Pfizer Investigational Site
Malmö, 205 02
Pfizer Investigational Site
Munkfors, 684 23
Pfizer Investigational Site
Nässjö, 576 81
Pfizer Investigational Site
Östersund, 831 31
Pfizer Investigational Site
Oxie, 238 40
Pfizer Investigational Site
Partille, 43323
Pfizer Investigational Site
Rättvik, 795 21
Pfizer Investigational Site
Sandviken, 811 60
Pfizer Investigational Site
Särö, 429 13
Pfizer Investigational Site
Sjuntorp, 460 20
Pfizer Investigational Site
Sollebrunn, 466 30
Pfizer Investigational Site
Stockholm, 112 35
Pfizer Investigational Site
Stockholm, 116 32
Pfizer Investigational Site
Sunne, 686 22
Pfizer Investigational Site
Trollhättan, 461 59
Pfizer Investigational Site
Tullinge, 146 31
Pfizer Investigational Site
Tyreso, 13521
Pfizer Investigational Site
Umeå, 901 85
Pfizer Investigational Site
Upplands Vasby, 194 04
Pfizer Investigational Site
Uppsala, 751 25
Pfizer Investigational Site
Vännäs, 911 82
Pfizer Investigational Site
Värnamo, 33185
Pfizer Investigational Site
Västerås, 722 11
Pfizer Investigational Site
Vaxjo, 350 04
Pfizer Investigational Site
Vaxjo, 352 41
Pfizer Investigational Site
Visby, 621 84
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Six-month, Multicenter, Double-blind, Parallel, Placebo-controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- Donepezil (Aricept), Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil (Aricept)Drug
Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment
PlaceboDrug
Matching placebo tablets orally once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Donepezil (Aricept) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score
Measured: Month 6
Change from baseline in Severe Impairment Battery (SIB) total score
Measured: Month 6
Secondary outcomes (6)
Change from baseline in SIB total score
Measured: Month 3
Change from baseline in Neuropsychiatric Inventory (NPI) total score
Measured: Months 3 and 6
Change from inclusion in Mini Mental State Examination (MMSE) total score
Measured: Month 6
Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
Measured: Months 3 and 6
Adverse events and laboratory value changes
Measured: Months 3 and 6
Change from baseline in modified ADCS-ADL-severe total score
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startOct 2002
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630851
- Sponsor's protocol ID
- A2501017
- Status last verified
- Mar 2015
- First submitted
- 27 Feb 2008
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month, Multicenter, Double-blind, Parallel, Placebo-controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility
- ClinicalTrials.gov ID
- NCT00630851
- Acronym / sponsor ID
- A2501017
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Oct 2004 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Donepezil (Aricept) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Probable or possible Alzheimer's disease
- Living in skilled nursing home
Key exclusion criteria (2 listed)
- Other types of dementia or psychiatric or neurologic disorders
- Musculoskeletal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil (Aricept)Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment | Drug | 1 |
| PlaceboMatching placebo tablets orally once daily for 6 months | Drug | 2 |
Primary outcome
Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score
Time frame: Month 6
Change from baseline in Severe Impairment Battery (SIB) total score
Time frame: Month 6
6 secondary outcomes
Change from baseline in SIB total score
Time frame: Month 3
Change from baseline in Neuropsychiatric Inventory (NPI) total score
Time frame: Months 3 and 6
Change from inclusion in Mini Mental State Examination (MMSE) total score
Time frame: Month 6
Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
Time frame: Months 3 and 6
Adverse events and laboratory value changes
Time frame: Months 3 and 6
Change from baseline in modified ADCS-ADL-severe total score
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Donepezil (Aricept) in people with Alzheimer Disease, run by Pfizer at 53 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.