Alzheimer DiseasePhase 3NCT00006187
The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
A Phase 3 study testing Investigational drug in people with Alzheimer Disease, run by Merck Sharp & Dohme LLC at 34 sites in United States.
Trial summary
This is a 15-month study with two phases. During the first 12-month phase of this study, patients will be randomly assigned to receive either active study drug or placebo (approximately half of all patients will be on active study drug, the other half on placebo). 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?
- Investigational drug
- How many people
- Not given
- Where
- 34 sitesUnited States
- Study dates
- Start not givento Jun 2005
- 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
- Patient is male or female and at least 50 years of age or older
- Female patients must be postmenopausal or surgically sterilized
- Clinical diagnosis of AD
- Patient must be in good health except for AD diagnosis
- Patient must have informant/caregiver who can monitor and assist patient during the study
Who cannot join
- Patient is living in a nursing home or skilled nursing facility
- Women will be ineligible if not postmenopausal or surgically sterilized
- Site physician or Sponsor may exclude patients with serious medical problems such as cancer, cardiovascular disease, major neurological or psychiatric illness, thyroid disease, or major head trauma
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
California Clinical Trials
Beverly Hills, California, 90211
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, 33486
Chicago Center for Clinical Research
Chicago, Illinois, 60610
ICSL Clinical Studies
East Providence, Rhode Island, 02915
Institute for Advanced Clinical Research
Elkins Park, Pennsylvania, 19027
Baumel-Eisner Neuromedical Institute
Fort Lauderdale, Florida, 33321
ICSL Clinical Studies
Fort Myers, Florida, 33907
Las Vegas Center for Clinical Research
Las Vegas, Nevada, 89146
Pharmacology Research Institute
Los Alamitos, California, 90720
ICSL Clinical Studies
Melbourne, Florida, 32935
Froedtert Lutheran Memorial Hospital
Milwaukee, Wisconsin, 53226
Yale University, Alzheimer's Disease ResearchUnit
New Haven, Connecticut, 06520-8037
Pharmacology Research Institute
Newport Beach, California, 92660
Daniel Grosz MD
Northridge, California, 91324
Pahl Brain Associates, P.C.
Oklahoma City, Oklahoma, 73118
Nathan Klein Institute
Orangeburg, New York, 10962
Pivotal Research Centers
Peoria, Arizona, 85381
ICSL Clinical Studies
Philadelphia, Pennsylvania, 19106
Pacific NW Clinical Research Center
Portland, Oregon, 97223
Pharmacology Research Institute
Riverside, California, 92506
University of Rochester
Rochester, New York, 14620
Pharmacology Research Clinic
Salt Lake City, Utah, 84107
Pacific Research Network
San Diego, California, 92103
San Francisco Headache Clinic
San Francisco, California, 94109
ICSL Clinical Studies
Sarasota, Florida, 34232
Seattle Clinical Research Center
Seattle, Washington, 98104
ICSL Clinical Studies
South Yarmouth, Massachusetts, 02664
ICSL Clinical Studies
St. Petersburg, Florida, 33702
Meridien Research
St. Petersburg, Florida, 33710
New England Center for Headache
Stamford, Connecticut, 06902
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, 74104-5428
Premiere Research Institute
West Palm Beach, Florida, 33407
Palm Beach Neurological Center
West Palm Beach, Florida, 33410
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
This is a 15-month study with two phases. During the first 12-month phase of this study, patients will be randomly assigned to receive either active study drug or placebo (approximately half of all patients will be on active study drug, the other half on placebo). The second phase is a 3-month randomized withdrawal period. For this phase approximately 10% of the patients will remain on the active drug.
Read the detailed description
This is a placebo-controlled, parallel-groups, 12 month, double-blind study, followed by a 3-month, double-blind, randomized withdrawal period to evaluate the efficacy and safety of an investigational drug (currently approved for other indications) to slow the progression of symptoms of AD. Patients with probable AD according to NINCDS-ADRDA criteria who have a Mini Mental State Examination (MMSE) score between 13 and 26 inclusive will be eligible for participation in the study.
Patients on stable doses of marketed cholinesterase inhibitors approved for the treatment of AD (except for tacrine) for at least 3 months are eligible for study entry. Use of NSAIDs (except aspirin 81 mg per day) is not allowed during the study.
- Conditions
- Alzheimer Disease
- Being tested
- Investigational drug
- Keywords
- Investigational Drug
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational drugDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2000 (estimated)
- Primary completionJun 2005 (estimated)
- Study completionJun 2005 (estimated)
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 Merck Sharp & Dohme LLCThe 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
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klaus Beck, MD, PhD, Principal investigator, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006187
- Sponsor's protocol ID
- IA0025
- Status last verified
- Oct 2003
- First submitted
- 25 Aug 2000
- Last updated
- 11 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00006187
- Acronym / sponsor ID
- IA0025
- Conditions
- Alzheimer Disease
- Keywords
- Investigational Drug
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Primary completion
- Jun 2005 (estimated)
- Study completion
- Jun 2005 (estimated)
- First posted
- 28 Aug 2000 (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.
This is a 15-month study with two phases. During the first 12-month phase of this study, patients will be randomly assigned to receive either active study drug or placebo (approximately half of all patients will be on active study drug, the other half on placebo). The second phase is a 3-month randomized withdrawal period. For this phase approximately 10% of the patients will remain on the active drug.
Detailed description
This is a placebo-controlled, parallel-groups, 12 month, double-blind study, followed by a 3-month, double-blind, randomized withdrawal period to evaluate the efficacy and safety of an investigational drug (currently approved for other indications) to slow the progression of symptoms of AD. Patients with probable AD according to NINCDS-ADRDA criteria who have a Mini Mental State Examination (MMSE) score between 13 and 26 inclusive will be eligible for participation in the study.
Patients on stable doses of marketed cholinesterase inhibitors approved for the treatment of AD (except for tacrine) for at least 3 months are eligible for study entry. Use of NSAIDs (except aspirin 81 mg per day) is not allowed during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is male or female and at least 50 years of age or older
- Female patients must be postmenopausal or surgically sterilized
- Clinical diagnosis of AD
- Patient must be in good health except for AD diagnosis
- Patient must have informant/caregiver who can monitor and assist patient during the study
Key exclusion criteria (3 listed)
- Patient is living in a nursing home or skilled nursing facility
- Women will be ineligible if not postmenopausal or surgically sterilized
- Site physician or Sponsor may exclude patients with serious medical problems such as cancer, cardiovascular disease, major neurological or psychiatric illness, thyroid disease, or major head trauma
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 |
|---|---|---|
| Investigational drug | 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 11 Dec 2009.
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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.
Klaus Beck, MD, PhD principal investigator
Merck Sharp & Dohme LLC
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational drug in people with Alzheimer Disease, run by Merck Sharp & Dohme LLC at 34 sites in United States.
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 5 inclusion and 3 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 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. 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 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 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 11 Dec 2009.