Dementia, VascularPhase 3NCT00035191
A Placebo-controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia
A Phase 3 study testing galantamine in people with Dementia, Vascular, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
This is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dementia, Vascular
- What is being tested?
- galantamine
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Sep 2003
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with vascular dementia per NINDS-AIREN criteria
- Radiologic evidence of VaD on MRI
- Clinical evidence of VaD (ie focal signs)
- Onset of dementia between ages 40 and 90 years
- Ability to read, write, communicate, and understand cognitive testing instructions
- No uncontrolled medical conditions
Who cannot join
- Presence of other diseases or disorders that could cause loss of mental functioning (such as trauma, cancer, infections, mental retardation)
- Current significant cardiovascular disease that could limit the patient's ability to complete the study
- Major psychiatric diseases
- Peptic ulcer or significant urine outflow obstructions
- Seizures
- Other serious diseases
- History of drug or alcohol abuse within the past year
About this study
Official title: A Randomized 26-Week, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia
This is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain.
Read the detailed description
In a previous 6-month study in patients with both vascular dementia and Alzheimer's dementia, galantamine demonstrated positive results on thinking, functioning, behavior, speech and overall well being of patients, and prevented the behavior symptoms of dementia from appearing. This combined study consists of two almost identical 26-week studies that examine the same criteria as the previous study, but in a larger patient population (dementia has been identified as having been caused by blood vessel disease without Alzheimer's disease). The study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day. Effectiveness will be measured by changes in scores on the Alzheimer's Disease Assessment Scale cognitive subscale, Alzheimer's Disease Cooperative Study Scale, the Clinician's Interview-Based Impression of Change Plus, and the neuropsychiatric inventory, as well as (in English-speaking countries only) a 10-minute interview of the patient (EXIT-25 scale). Safety will be evaluated throughout the study based on the incidence and severity of unexpected events, laboratory and physical tests, and vital signs. The hypothesis of the study is that galantamine will improve thinking, function, behavior, speech, and overall well being, better than placebo. A voluntary pharmacogenomic study will be incorporated into the study plan to evaluate whether specific genes are related to the dementia or drug response. 8 milligrams (mg) 2 times a day for 8 weeks, then increasing to12 mg, if tolerated. After 12 weeks dose can be reduced to 8 mg or matching placebo
- Conditions
- Dementia, Vascular
- Being tested
- galantamine
- Keywords
- Dementia, vascular dementia, cerebral vascular disease
- Medical subject headings
- Dementia, Vascular, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galantamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 26 in Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-cog)
Secondary outcomes (1)
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus) score and ADCS-ADL Inventory; neuropsychiatric inventory (NPI); in English-speaking countries only, the EXIT-25 scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startOct 2001
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, VascularStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035191
- Sponsor's protocol ID
- CR002011
- Status last verified
- Nov 2010
- First submitted
- 2 May 2002
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized 26-Week, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia
- ClinicalTrials.gov ID
- NCT00035191
- Acronym / sponsor ID
- CR002011
- Conditions
- Dementia, Vascular
- Keywords
- Dementia, vascular dementia, cerebral vascular disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Sep 2003 (actual)
- First posted
- 3 May 2002 (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 trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain.
Detailed description
In a previous 6-month study in patients with both vascular dementia and Alzheimer's dementia, galantamine demonstrated positive results on thinking, functioning, behavior, speech and overall well being of patients, and prevented the behavior symptoms of dementia from appearing. This combined study consists of two almost identical 26-week studies that examine the same criteria as the previous study, but in a larger patient population (dementia has been identified as having been caused by blood vessel disease without Alzheimer's disease). The study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day. Effectiveness will be measured by changes in scores on the Alzheimer's Disease Assessment Scale cognitive subscale, Alzheimer's Disease Cooperative Study Scale, the Clinician's Interview-Based Impression of Change Plus, and the neuropsychiatric inventory, as well as (in English-speaking countries only) a 10-minute interview of the patient (EXIT-25 scale). Safety will be evaluated throughout the study based on the incidence and severity of unexpected events, laboratory and physical tests, and vital signs. The hypothesis of the study is that galantamine will improve thinking, function, behavior, speech, and overall well being, better than placebo. A voluntary pharmacogenomic study will be incorporated into the study plan to evaluate whether specific genes are related to the dementia or drug response. 8 milligrams (mg) 2 times a day for 8 weeks, then increasing to12 mg, if tolerated. After 12 weeks dose can be reduced to 8 mg or matching placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with vascular dementia per NINDS-AIREN criteria
- Radiologic evidence of VaD on MRI
- Clinical evidence of VaD (ie focal signs)
- Onset of dementia between ages 40 and 90 years
- Ability to read, write, communicate, and understand cognitive testing instructions
Key exclusion criteria (7 listed)
- Presence of other diseases or disorders that could cause loss of mental functioning (such as trauma, cancer, infections, mental retardation)
- Current significant cardiovascular disease that could limit the patient's ability to complete the study
- Major psychiatric diseases
- Peptic ulcer or significant urine outflow obstructions
- Seizures
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 |
|---|---|---|
| galantamine | Drug | – |
Primary outcome
Change from baseline to week 26 in Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-cog)
1 secondary outcome
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus) score and ADCS-ADL Inventory; neuropsychiatric inventory (NPI); in English-speaking countries only, the EXIT-25 scale.
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 8 Jun 2011.
- Placebo Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular DementiaLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing galantamine in people with Dementia, Vascular, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 6 inclusion and 7 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 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 to week 26 in Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-cog). 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 8 Jun 2011.