DementiaNCT01029132
Characteristics of Treatment Responders to Galantamine
A study testing galantamine in people with Dementia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To investigate the characteristics of treatment responders to galantamine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- galantamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2007to Oct 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Who cannot join
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease
To investigate the characteristics of treatment responders to galantamine.
Read the detailed description
The purposes of this study are:
- to investigate the characteristics of treatment responders to galantamine by examining the clinical response of galantamine in patients with mild to moderate AD for 52 weeks.
- to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.
- Conditions
- Dementia
- Being tested
- galantamine
- Keywords
- Alzheimer's disease, Galantamine, Treatment response, Efficacy, Adverse Event
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galantamineDrug
Also called galantamine-reminyl
8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability
| Study group | Role | What they receive |
|---|---|---|
| non-responder group | Experimental | patients who did not maintained or improved cognitive function Receives: Drug: galantamine |
| responder group | Experimental | patients who maintained or improved cognitive function Receives: Drug: galantamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
Measured: baseline, 4w, 13w, 26w, 39w, 52w
Secondary outcomes (1)
Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)
Measured: baseline, 4w, 13w, 26w, 39w, 52w
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startApr 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Responsible party
- Principal investigator, Doh Kwan Kim, Samsung Medical Center
- Investigators
- Doh Kwan Kim, PhD, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029132
- Sponsor's protocol ID
- 2007-04-021
- Status last verified
- Jan 2016
- First submitted
- 6 Dec 2009
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01029132
- Acronym / sponsor ID
- 2007-04-021
- Conditions
- Dementia
- Keywords
- Alzheimer's disease, Galantamine, Treatment response, Efficacy, Adverse Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Apr 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Dec 2009 (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.
To investigate the characteristics of treatment responders to galantamine.
Detailed description
The purposes of this study are:
- to investigate the characteristics of treatment responders to galantamine by examining the clinical response of galantamine in patients with mild to moderate AD for 52 weeks.
- to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-responder group | Experimental | Drug: galantaminepatients who did not maintained or improved cognitive function |
| responder group | Experimental | Drug: galantaminepatients who maintained or improved cognitive function |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Key exclusion criteria (5 listed)
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
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 |
|---|---|---|
| galantamineAlso: galantamine-reminyl8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability | Drug | non-responder group, responder group |
Primary outcome
Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
Time frame: baseline, 4w, 13w, 26w, 39w, 52w
1 secondary outcome
Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)
Time frame: baseline, 4w, 13w, 26w, 39w, 52w
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 6 Jan 2016.
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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.
Doh Kwan Kim, PhD, M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing galantamine in people with Dementia, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 5 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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?
Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K) (time frame: baseline, 4w, 13w, 26w, 39w, 52w). 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 6 Jan 2016.