DementiaPhase 4NCT00814658

The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life

A Phase 4 study testing Galantamine and Nimodipine in people with Dementia, run by Janssen-Cilag Farmaceutica Ltda..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Dementia
What is being tested?: Galantamine and Nimodipine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: No sites listed yet
Study dates: Jun 2008to Oct 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Patients should fulfill DSM-IV criteria for dementia (APA, 1994)
Patients should fulfill criteria for AD with cerebrovascular disease according to NINDS-AIREN criteria (Román et al., 1993)
The severity of dementia should be mild to moderate, as defined by MMSE score between 10 and 26 (inclusive)
Patients (and their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Who cannot join

History of neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease. Patients who have mild extrapyramidal signs, for which no treatment is required, are not excluded from the trial
History of liver or renal insufficiency
significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbances in the past 6 months
Patients who have previously received M1 agonists or cholinesterase inhibitors (tacrine, donepezil, metrifonate, rivastigmine) for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided there was at least a washout period of 60 days prior to the screening assessments
History of drug or alcohol abuse within the last year or prior prolonged history
History of severe drug allergy or hypersensitivity
including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide
Subjects who have previously been enrolled in other galantamine trials.

About this study

The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.

Read the detailed description

A double-blind (neither the patient nor the physician know the name of the study drug), 6-month, multicenter, placebo-controlled trial to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life. The target dose of galantamine is 24 mg/day and nimodipine will be taken in fixed doses of 90 mg/day. Primary outcomes will be measured by a computerized battery of neuropsychological tests and Quality of Life (QoL) scores. Secondary outcomes will be measured by ADAS-cog, Clinical Global Impression (CGI) and Neuropsychiatric Inventory (NPI). Mixed dementia (Alzheimer's Disease (AD) associated with cerebrovascular disease) is one of the most common causes of dementia, which remain largely underdiagnosed. Little is known about specific treatments for this condition. Ischemic lesions by themselves seem to play an important role in cognitive impairment, even in the presence of AD pathology. Hypotheses: - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) in improving or stabilizing cognition in patients with AD associated with cerebrovascular disease (mixed dementia), as measured by the CNTB at 6 months. - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) on QoL measures in this population as measured by QoL - AD at 6 months. Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus nimodipine oral 30mg tid during all study. Group 2: Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus placebo oral 30mg tid during all study.

Conditions: Dementia
Being tested: Galantamine, Nimodipine, Placebo
Keywords: Dementia, Mixed Dementia, Galantamine, Reminyl ER, Nimodipine
Medical subject headings: Dementia, Mixed Dementias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GalantamineDrug
Galantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day.
NimodipineDrug
Nimodipine 30 mg 3 times a day (tid).
PlaceboDrug
Matching placebo three times a day (tid).

Study groups in NCT00814658
Study group	Role	What they receive
Galantamine + Nimodipine	Experimental	Not described Receives: Drug: Galantamine; Drug: Nimodipine
Galantamine + Placebo	Experimental	Not described Receives: Drug: Galantamine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24
The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient's finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Measured: Baseline, Week 8, Week 24
Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24
The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient's right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Measured: Baseline, Week 8, Week 24
Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24
The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.
Measured: Baseline, Week 8, Week 24
Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24
The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient's reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Measured: Baseline, Week 8, Week 24
The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
The Quality of Life assessment scale for caregivers of patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.
Measured: Baseline, Week 8, Week 24
The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.
Measured: Baseline, Week 8, Week 24
The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24
The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.
Measured: Baseline, Week 8, Week 24

Secondary outcomes (3)

The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24
The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.
Measured: Baseline, Week 8, Week 24
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
The Clinical Global Impression (CGI) is a scale to assess treatment response in patients with mental disorders. The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Measured: Week 4, Week 8, Week 16, Week 24
The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24
The NPI evaluates 12 neuropsychiatric domains: delusions, hallucinations, dysphoria, anxiety, aggression, euphoria, dis-inhibition, irritability/lability, apathy, aberrant motor activity, eating disorders, and night-time behavior disturbances. For present domains, the severity and frequency of the behavior are determined. Frequency is rated 1 (rarely) to 4 (very often) and Severity is scored 1 (mild) to 3 (severe). The product scores vary from 1 (mild and rarely) to 12 (very often and severe). Total scores vary from 0 (no present domain) to 144 (all domains are present, are often and severe).
Measured: Baseline, Week 8, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Oct 2009

First posted25 Dec 2008 (estimated)
Study startJun 2008
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DementiaStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00814658
Sponsor's protocol ID: CR014938
Other IDs: GALDEM4008
Status last verified: Aug 2013
First submitted: 24 Dec 2008
Last updated: 26 Aug 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Caramelli P, Laks J, Palmini AL, Nitrini R, Chaves ML, Forlenza OV, Vale Fde A, Barbosa MT, Bottino CM, Machado JC, Charchat-Fichman H, Lawson FL. Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study). Arq Neuropsiquiatr. 2014 Jun;72(6):411-7. doi: 10.1590/0004-282x20140055.
PubMed 24964105

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
ClinicalTrials.gov ID: NCT00814658
Acronym / sponsor ID: CR014938
Conditions: Dementia
Keywords: Dementia, Mixed Dementia, Galantamine, Reminyl ER, Nimodipine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.Industry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 25 Dec 2008 (estimated)
Results: Posted 26 Aug 2013

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 combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Galantamine + Nimodipine	Experimental	Drug: Galantamine, Drug: Nimodipine
Galantamine + Placebo	Experimental	Drug: Galantamine, Drug: Placebo

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Patients should fulfill DSM-IV criteria for dementia (APA, 1994)
Patients should fulfill criteria for AD with cerebrovascular disease according to NINDS-AIREN criteria (Román et al., 1993)
The severity of dementia should be mild to moderate, as defined by MMSE score between 10 and 26 (inclusive)
Patients (and their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Key exclusion criteria (8 listed)

History of neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease. Patients who have mild extrapyramidal signs, for which no treatment is required, are not excluded from the trial
History of liver or renal insufficiency
significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbances in the past 6 months
Patients who have previously received M1 agonists or cholinesterase inhibitors (tacrine, donepezil, metrifonate, rivastigmine) for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided there was at least a washout period of 60 days prior to the screening assessments
History of drug or alcohol abuse within the last year or prior prolonged history

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
GalantamineGalantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day.	Drug	Galantamine + Nimodipine, Galantamine + Placebo
NimodipineNimodipine 30 mg 3 times a day (tid).	Drug	Galantamine + Nimodipine
PlaceboMatching placebo three times a day (tid).	Drug	Galantamine + Placebo

Primary outcome

Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24
Time frame: Baseline, Week 8, Week 24
The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient's finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24
Time frame: Baseline, Week 8, Week 24
The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient's right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24
Time frame: Baseline, Week 8, Week 24
The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.
Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24
Time frame: Baseline, Week 8, Week 24
The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient's reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).
The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
Time frame: Baseline, Week 8, Week 24
The Quality of Life assessment scale for caregivers of patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.
The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
Time frame: Baseline, Week 8, Week 24
The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.
The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24
Time frame: Baseline, Week 8, Week 24
The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.

3 secondary outcomes

The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24
Time frame: Baseline, Week 8, Week 24
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
Time frame: Week 4, Week 8, Week 16, Week 24
The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24
Time frame: Baseline, Week 8, Week 24

Results and safety

Results posted to the registry on 26 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Galantamine + Nimodipine	9	5
Galantamine + Placebo	12	8

Primary outcome: Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24

Time frame: Baseline, Week 8, Week 24. Mean (Standard Deviation). Unit: milliseconds

Measure	Galantamine + Nimodipine (Baseline) n = 9	Galantamine + Placebo (Baseline) n = 12	Galantamine + Nimodipine (Week 8) n = 5	Galantamine + Placebo (Week 8) n = 9	Galantamine + Nimodipine (Week 24) n = 5	Galantamine + Placebo (Week 24) n = 8
Value	1024.06 (1307.97)	729.18 (394.88)	466.60 (297.53)	671.33 (298.38)	467.60 (336.69)	584.44 (320.37)

Population analysed: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.

Primary outcome: Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24

Time frame: Baseline, Week 8, Week 24. Mean (Standard Deviation). Unit: milliseconds

Measure	Galantamine + Nimodipine (Baseline) n = 9	Galantamine + Placebo (Baseline) n = 12	Galantamine + Nimodipine (Week 8) n = 5	Galantamine + Placebo (Week 8) n = 9	Galantamine + Nimodipine (Week 24) n = 5	Galantamine + Placebo (Week 24) n = 8
Value	1919.72 (1801.13)	1096.75 (617.45)	852.70 (480.79)	1187.78 (637.60)	727.60 (375.03)	1116.25 (540.91)

Primary outcome: Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24

Time frame: Baseline, Week 8, Week 24. Mean (Standard Deviation). Unit: milliseconds

Measure	Galantamine + Nimodipine (Baseline) n = 9	Galantamine + Placebo (Baseline) n = 12	Galantamine + Nimodipine (Week 8) n = 5	Galantamine + Placebo (Week 8) n = 9	Galantamine + Nimodipine (Week 24) n = 5	Galantamine + Placebo (Week 24) n = 8
Value	3124.00 (1461.46)	2684.45 (1315.44)	2262.50 (803.30)	2734.25 (1252.62)	2357.80 (1919.72)	3099.38 (1823.80)

Primary outcome: Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24

Time frame: Baseline, Week 8, Week 24. Mean (Standard Deviation). Unit: milliseconds

Measure	Galantamine + Nimodipine (Baseline) n = 9	Galantamine + Placebo (Baseline) n = 12	Galantamine + Nimodipine (Week 8) n = 5	Galantamine + Placebo (Week 8) n = 9	Galantamine + Nimodipine (Week 24) n = 5	Galantamine + Placebo (Week 24) n = 8
Value	2022.17 (672.08)	2978.77 (1867.62)	1966.40 (1252.10)	2379.83 (984.52)	1722.00 (1174.22)	3038.81 (1243.79)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Galantamine + Nimodipine	1 of 9 (11.1%)	8 of 9 (88.9%)	Not reported
Galantamine + Placebo	1 of 12 (8.3%)	10 of 12 (83.3%)	Not reported

Limitations and caveats (from the sponsor): The major limitation of this study was the small sample size. This was probably due to the short enrollment period and to the rigorous inclusion criteria that were adopted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24964105Caramelli P, Laks J, Palmini AL, Nitrini R, Chaves ML, Forlenza OV, Vale Fde A, Barbosa MT, Bottino CM, Machado JC, Charchat-Fichman H, Lawson FL. Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study). Arq Neuropsiquiatr. 2014 Jun;72(6):411-7. doi: 10.1590/0004-282x20140055.

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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-Cilag Farmaceutica Ltda. Clinical Trial study director

Janssen-Cilag Farmaceutica Ltda.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Galantamine and Nimodipine in people with Dementia, run by Janssen-Cilag Farmaceutica Ltda..

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 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: finished, as of the sponsor's last update on 26 Aug 2013. 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 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?

Yes. Results are posted in the registry (first posted 26 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24 (time frame: Baseline, Week 8, Week 24). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00814658, which also lists 1 linked publication.

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 Aug 2013.