Alzheimer's DiseasePhase 2NCT00087724
A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing FK962 in people with Alzheimer's Disease, run by Astellas Pharma Inc at 84 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- FK962
- How many people
- 510 participants
- Where
- 84 sitesin 2 countries
- Study dates
- Jul 2004to Sep 2006
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject satisfies the criteria for the clinical diagnosis of probable AD
- Subject has a score =< 4 on the Modified Hachinski Ischemia Scale at the screening visit
Who cannot join
- Subject has history or evidence of significant neurologic disease other than AD
- Subject has a history of stroke
- Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years
- Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry
- Subject has medically unstable COPD or asthma
- Subject has end stage CHF (NYHA Class III or IV) or unstable angina
- Subject has evidence of significant renal insufficiency
- Subject has insulin-dependent diabetes mellitus or HbA1C>8.5% at screening
Trial locations and contacts
84 sites in 2 countries.
84 sites in 2 countries
United States72 sites
Investigational Site
Albany, New York, 12208
Investigational Site
Albuquerque, New Mexico, 87102
Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Study site
Baltimore, Maryland, 21208
Investigational Site
Bennington, Vermont, 05201
Investigational Site
Buffalo, New York, 14221
Study site
Burlington, Vermont, 05401
Investigational Site
Centerville, Ohio, 45459
Study site
Charlotte, North Carolina, 28204
Investigational Site
Columbus, Ohio, 43210
Investigational Site
Darien, Connecticut, 06820
Study site
Dayton, Ohio, 45408
Investigational Site
Dayton, Ohio, 45415
Investigative Site
Denver, Colorado, 80249
Investigational Site
Denver, Colorado, 80262
Investigational Site
Elk Grove, Illinois, 60007
Investigational Site
Eugene, Oregon, 97401
Investigational Site
Fort Myers, Florida, 33912
Investigational Site
Fresno, California, 93720
Investigational Site
Hamden, Connecticut, 06518
Study site
Hamden, Connecticut, 06518
Study site
Hattiesburg, Mississippi, 32401
Investigational Site
Hialeah, Florida, 33016
Investigational Site
Hollywood, Florida, 33021
Investigational Site
Houston, Texas, 77063
Investigational Site
Irvine, California, 92618
Investigational Site
Jenkintown, Pennsylvania, 19046
Investigational Site
Johnson City, Tennessee, 37601
Investigational Site
Las Vegas, Nevada, 89102
Investigational Site
Lawrence, New York, 11559
Investigational Site
Little Rock, Arkansas, 72205
Investigational Site
Little Rock, Arkansas, 72211
Study site
Livonia, Michigan, 48152
Investigational Site
Long Branch, New Jersey, 07740
Investigational Site
Medford, Oregon, 97504
Investigational Site
Miami, Florida, 33176
Investigational Site
Milwaukee, Wisconsin, 53227
Investigational Site
Nashville, Tennessee, 37203
Investigational Site
New Orleans, Louisiana, 70112
Investigational Site
New York, New York, 10021
Investigational Site
Newton, Massachusetts, 02459
Investigational Site
Norfolk, Virginia, 23507
Investigational Site
North Miami, Florida, 33161
Investigational Site
Ocala, Florida, 34471
Investigational Site
Oklahoma City, Oklahoma, 73112
Investigational Site
Orange, California, 92656
Investigational Site
Paterson, New Jersey, 08759
Investigational Site
Pawtucket, Rhode Island, 02860
Investigational Site
Phoenix, Arizona, 85013
Investigational Site
Phoenix, Arizona, 85032
Investigational Site
Piscataway, New Jersey, 08855
Investigational Site
Port Charlotte, Florida, 33952
Investigational Site
Salt Lake City, Utah, 84121
Investigational Site
San Antonio, Texas, 78229
Investigational Site
San Francisco, California, 94115
Investigational Site
Sarasota, Florida, 34243
Investigational Site
Sebring, Florida, 33872
Investigational Site
Sherman Oaks, California, 91403
Investigational Site
Snellville, Georgia, 30078
Study site
Snellville, Georgia, 30078
Investigational Site
St Louis, Missouri, 63128
Investigational Site
Stamford, Connecticut, 06902
Study site
Sun City, Arizona, 85351
Investigational Site
Tampa, Florida, 33613
Investigational Site
Toledo, Ohio, 43623
Investigational Site
Torrance, California, 90505
Investigational Site
Tucson, Arizona, 85724
Investigational Site
Tulsa, Oklahoma, 74104
Study site
West Palm Beach, Florida, 33407
Investigational Site
White Plains, New York, 10605
Investigational Site
Wichita, Kansas, 67207
Investigational Site
Wichita Falls, Texas, 76309
Canada12 sites
Investigational Site
Barrie, Ontario, L4M4S5
Investigational Site
Greater Sudbury, Ontario, P3E6B4
Investigational Site
Kelowna, British Columbia, V1Y3G8
Investigational Site
North York, Ontario, M2J5A3
Investigational Site
North York, Ontario, M6M3C5
Investigational Site
Ottawa, Ontario, K1G 4C3
Investigational Site
Penticton, British Columbia, V2A5C8
Investigational Site
Regina, Saskatchewan, S4T1A5
Investigational Site
Sydney, Nova Scotia, B1P1C6
Investigational Site
Toronto, Ontario, M6M3Z5
Investigational Site
Victoria, British Columbia, V8T5G1
Investigational Site
Willowdale, Ontario, M2K2Z3
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects With Mild to Moderate Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.
- Conditions
- Alzheimer's Disease
- Being tested
- FK962
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK962Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2004 (estimated)
- Study startJul 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 510 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087724
- Sponsor's protocol ID
- 03-0-189
- Status last verified
- Jun 2012
- First submitted
- 12 Jul 2004
- Last updated
- 7 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00087724
- Acronym / sponsor ID
- 03-0-189
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 510 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Jul 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 14 Jul 2004 (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 this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject satisfies the criteria for the clinical diagnosis of probable AD
- Subject has a score =< 4 on the Modified Hachinski Ischemia Scale at the screening visit
Key exclusion criteria (8 listed)
- Subject has history or evidence of significant neurologic disease other than AD
- Subject has a history of stroke
- Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years
- Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry
- Subject has medically unstable COPD or asthma
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 |
|---|---|---|
| FK962 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
Related trials for Alzheimer's Disease
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
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.
Use Central Contact study director
Astellas Pharma US, Inc.
84 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK962 in people with Alzheimer's Disease, run by Astellas Pharma Inc at 84 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 8 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: stopped early, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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.
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 7 Jun 2012.