Alzheimer's DiseasePhase 4NCT01478633
Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
A Phase 4 study testing Galantamine in people with Alzheimer's Disease, run by Janssen Pharmaceutical K.K. at 11 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of galantamine in patients who failed to benefit from donepezil (patients switching from donepezil). In clinical practice, it is expected that galantamine will be used in patients switching from donepezil due to the insufficient efficacy of donepezil. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Galantamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 11 sitesJapan
- Study dates
- Sep 2011to Jun 2013
- Phase
- Phase 4
- 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
- Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group
- Have an MMSE score of 10 to 22 inclusive at screening
- Have taken donepezil stably at 5 mg/day for more than 6 months before screening
- Have progression (worsening) of impaired cognitive function 6 months or longer before screening
- Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Be medically stable on the basis of clinical laboratory tests performed at screening
Who cannot join
- Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type
- Has suspected impaired cognitive function due to a variety of causes
- Has significant health disorders or diseases according to the investigators' detailed criteria
- Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study
- Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study
- Has a history of severe drug allergy or severe drug hypersensitivity
Show all 10Show fewer
- Has a history of drug or alcohol abuse
- Used another investigational drug within 90 days of screening
- Used anti-dementia drugs marketed or being developed other than donepezil or medications containing the same active ingredients within 6 months of screening
- Is considered as ineligible by the investigator
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Study site
Akita
Study site
Izunokuni
Study site
Kochi
Study site
Kumamoto
Study site
Osaka
Study site
Saitama
Study site
Takatsuki
Study site
Tokyo
Study site
Uji
Study site
Urayasu
Study site
Yokohama
About this study
Official title: Evaluation of Efficacy and Safety of Galantamine in Subjects With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
The purpose of this study is to evaluate the efficacy and safety of galantamine in patients who failed to benefit from donepezil (patients switching from donepezil). In clinical practice, it is expected that galantamine will be used in patients switching from donepezil due to the insufficient efficacy of donepezil.
Read the detailed description
This is a nonrandomized (study drug is intentionally assigned), open-label (all people involved know the identity of the intervention), single-arm (one group of patients receiving the same treatment), multi-centered study of galantamine in patients with Alzheimer's disease (AD). Galantamine has been approved for treatment of mild to moderate dementia of AD. Galantamine is available as film-coated tablet in 68 countries including the United States and Europe, and is also available as oral syrup and extended-release capsule in 65 counties. In Japan, galantamine was approved in January 2011 and is available in three dosage forms of film-coated tablet, oral disintegrant tablet, and oral syrup. The target population is patients with mild to moderate dementia of Alzheimer's type (ie, Mini-Mental State Examination [MMSE] ranging from 10 to 22) who failed to benefit from donepezil. Patients must have diagnosis of probable AD according to the diagnostic criteria National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) study group. To ensure that at least 100 subjects complete the study, 125 subjects will be enrolled. The treatment group is to receive flexible dosing of 16 mg/day or 24 mg/day. Patients will receive the study treatment for 24 weeks in accordance with the dosing regimen specified in the protocol.
- Conditions
- Alzheimer's Disease
- Being tested
- Galantamine
- Keywords
- Alzheimer's disease, Dementia, Galantamine, Donepezil
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalantamineDrug
8 mg/day (4 mg twice daily) for 4 weeks, followed by 16 mg/day (8 mg twice daily) for an additional 4 weeks, followed by dose at 16 mg or increased to 24 mg (with the option of decreasing back to 16 mg) for the remainder of the study (to week 24)
| Study group | Role | What they receive |
|---|---|---|
| Galantamine | Experimental | Not described Receives: Drug: Galantamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24
The ADAS-J cog scale assesses memory, language and behavior and is composed of 11 tasks: word recall, spoken language ability, auditory comprehension, word finding difficulty in spontaneous speech, following commands, object and finger naming, constructional praxis, ideational praxis, orientation, word recognition, and recalling test instructions. The perfect total score is 70 points, and as the score becomes higher, the degree of impairment becomes severer.
Measured: at Week 24
Secondary outcomes (2)
The Clinical Global Impression of Change (CGI-C) at Week 24
CGI-C is employed to evaluate the patient's global clinical improvement according to the rater's impression from 1 (Very much improved) to 7 (Very much worse).
Measured: at Week 24
Proportion of Responders at Week 24
Proportion of responders whose ADAS-J cog score at endpoint decreased from baseline.
Measured: at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionJun 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K. K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478633
- Sponsor's protocol ID
- CR018649
- Other IDs
- JNS023-JPN-02
- Status last verified
- Mar 2014
- First submitted
- 3 Nov 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Galantamine in Subjects With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
- ClinicalTrials.gov ID
- NCT01478633
- Acronym / sponsor ID
- CR018649
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, Dementia, Galantamine, Donepezil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Nov 2011 (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 efficacy and safety of galantamine in patients who failed to benefit from donepezil (patients switching from donepezil). In clinical practice, it is expected that galantamine will be used in patients switching from donepezil due to the insufficient efficacy of donepezil.
Detailed description
This is a nonrandomized (study drug is intentionally assigned), open-label (all people involved know the identity of the intervention), single-arm (one group of patients receiving the same treatment), multi-centered study of galantamine in patients with Alzheimer's disease (AD). Galantamine has been approved for treatment of mild to moderate dementia of AD. Galantamine is available as film-coated tablet in 68 countries including the United States and Europe, and is also available as oral syrup and extended-release capsule in 65 counties. In Japan, galantamine was approved in January 2011 and is available in three dosage forms of film-coated tablet, oral disintegrant tablet, and oral syrup. The target population is patients with mild to moderate dementia of Alzheimer's type (ie, Mini-Mental State Examination [MMSE] ranging from 10 to 22) who failed to benefit from donepezil. Patients must have diagnosis of probable AD according to the diagnostic criteria National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) study group. To ensure that at least 100 subjects complete the study, 125 subjects will be enrolled. The treatment group is to receive flexible dosing of 16 mg/day or 24 mg/day. Patients will receive the study treatment for 24 weeks in accordance with the dosing regimen specified in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galantamine | Experimental | Drug: Galantamine |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group
- Have an MMSE score of 10 to 22 inclusive at screening
- Have taken donepezil stably at 5 mg/day for more than 6 months before screening
- Have progression (worsening) of impaired cognitive function 6 months or longer before screening
- Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Key exclusion criteria (10 listed)
- Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type
- Has suspected impaired cognitive function due to a variety of causes
- Has significant health disorders or diseases according to the investigators' detailed criteria
- Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study
- Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study
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 |
|---|---|---|
| Galantamine8 mg/day (4 mg twice daily) for 4 weeks, followed by 16 mg/day (8 mg twice daily) for an additional 4 weeks, followed by dose at 16 mg or increased to 24 mg (with the option of decreasing back to 16 mg) for the remainder of the study (to week 24) | Drug | Galantamine |
Primary outcome
The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24
Time frame: at Week 24
The ADAS-J cog scale assesses memory, language and behavior and is composed of 11 tasks: word recall, spoken language ability, auditory comprehension, word finding difficulty in spontaneous speech, following commands, object and finger naming, constructional praxis, ideational praxis, orientation, word recognition, and recalling test instructions. The perfect total score is 70 points, and as the score becomes higher, the degree of impairment becomes severer.
2 secondary outcomes
The Clinical Global Impression of Change (CGI-C) at Week 24
Time frame: at Week 24
Proportion of Responders at Week 24
Time frame: at Week 24
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 26 Mar 2014.
- Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From DonepezilLink 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.
Janssen Pharmaceutical K. K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Galantamine in people with Alzheimer's Disease, run by Janssen Pharmaceutical K.K. at 11 sites in Japan.
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 10 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24 (time frame: at Week 24). 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 26 Mar 2014.