Alzheimer DiseasePhase 4NCT00035204
A Study of the Effects on Sleep, Attention, and Gastrointestinal Tolerance of Galantamine and Donepezil in Patients With Alzheimer's Disease
A Phase 4 study testing galantamine in people with Alzheimer Disease, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the relative effects of galantamine compared to donepezil (both cholinesteraste inhibitors), on sleep, attention, and gastrointestinal tolerance in patients with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- galantamine
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Start not givento May 2003
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or post-menopausal female out-patients diagnosed with Alzheimer's disease
- Patients should have mild to moderate dementia as evidenced by a Mini-Mental State Examination score of 10-24 inclusive at screening
- The patient must show a history of cognitive decline that has been gradual in onset and progressive over a period of at least six months
- There must be evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of the following five areas: orientation, judgement and problem solving, functioning in community affairs, functioning in home and hobbies, or functioning in personal care
- The caregiver resides with the patient and is able to speak with the investigative team about the patient's activities, medication use and adverse events. In addition, the caregiver will participate in assessment interviews and complete questionnaires for themselves and the patients. The caregiver will monitor their own sleep, the patient's sleep, and complete questionnaires regarding sleep patterns and care giving activities
Who cannot join
- Neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease
- One of the following conditions possibly resulting in cognitive impairment: acute cerebral trauma or injuries secondary to chronic trauma, hypoxic cerebral damage, e.g., post resuscitation (cardiac arrest, post anesthesia, secondary to severe self-poisoning episode, or secondary to severe hypovolemia)
- Patients with the following medical conditions: any history of epilepsy or convulsions except for febrile convulsions during childhood, clinically significant: endocrine disease, metabolic disease, psychiatric disease, cardiovascular disease, peptic ulcer disease, hepatic disease, renal disease, pulmonary disturbances or urinary outflow obstruction
- Use of any agent for the treatment of dementia (approved, experimental or over the counter agents) including patients who have previously received tacrin, donepazil, metrifonate, rivastigmine tartrate, galantamine, or memantine for treatment of Alzheimer's disease
About this study
Official title: A Double-blind, Randomized Pilot Study to Evaluate the Effects of Galantamine and Donepezil on Sleep and Attention and Gastrointestinal (GI) Tolerance in Patients With Mild to Moderate Alzheimer's Disease (AD)
The purpose of this study is to evaluate the relative effects of galantamine compared to donepezil (both cholinesteraste inhibitors), on sleep, attention, and gastrointestinal tolerance in patients with Alzheimer's disease.
Read the detailed description
This is designed as a pilot (preliminary) study to evaluate the differences in effects on attention, sleep problems and gastrointestinal tolerance associated with Alzheimer's Disease with two different drugs at two different doses. Patients must have mild to moderate Alzheimer's Disease based on the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria and a Mini-Mental State Examination (MMSE) score of 10 to 24. The trial will consist of a 2-week run-in phase, an 8-week assessment phase, and an extension phase of variable length (6 weeks to 54 weeks). During the study, patients will be randomized (assigned by chance) to receive either galantamine or donepezil. Galantamine will be given by mouth 4mg twice daily for Weeks 1-4 and then 8mg twice daily for Weeks 5-8 and beyond (for participants in the extension). The patients on donezepil will receive 5mg by mouth at bedtime for Weeks 1-4 and then 10mg at bedtime for Weeks 5-8 and beyond. Placebo tablets will be given so that each patient takes two capsules per dose in order to conceal the identity of the drugs. Neither the patient nor the physician will know which drug the patient is receiving. Drug effectiveness will be measured by change in overall functioning of the patient shown by the Clinician's Interview-Based Impression of Change Plus Family Input (CIBIC-Plus). Other tests to evaluate whether the drug is effective will include the change in results of attention tests (Simple Reaction Time [SRT], Choice Reaction Time [CRT], Verbal Series Attention Test [VSAT], and Stroop Test), and in sleep pattern tests (tests that measure movements during sleep [Actiwatch] and patterns of sleep such as the caregiver-completed Pittsburgh Sleep Quality Index [PSQI] and the Circadian Sleep Inventory for Normal and Pathological States [CSINAPS]). Measures of quality of life will include the Alzheimer's Disease Related Quality of Life Scale (ADRQL) and the caregiver-completed Allocation of Caregiver Time Survey (ACTS) and SF-12 Quality of Life Survey. Safety assessment and gastrointestinal tolerability will be based on recording the number and severity of unexpected and undesirable events as well as physical examination and vital signs. The exploratory study hypotheses are that galantamine will be superior to donezepil in improving attention, sleep patterns, and quality of life in patients with mild-to-moderate Alzheimer's disease and that it will be well tolerated by patients.
Patients will receive either galantamine 4mg twice daily by mouth or donepezil 5mg at bedtime . Then, either galantamine 8mg twice daily by mouth or donezepil 10 mg at bedtime by mouth (with placebo dose); the doses are continued into the double-blind extension phase (6 to 54 weeks).
- Conditions
- Alzheimer Disease
- Being tested
- galantamine
- Keywords
- Donepezil, Alzheimer's, Dementia, Cognitive impairment, Aricept, Alzheimer's disease, Razadyne, Galantamine
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
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.
To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance
Secondary outcomes (1)
To assess the tolerability, overall effect, quality of life and safety of galantamine compared with donepezil
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 completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035204
- Sponsor's protocol ID
- CR002002
- Status last verified
- Apr 2010
- First submitted
- 2 May 2002
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
PubMed 33189083
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 Double-blind, Randomized Pilot Study to Evaluate the Effects of Galantamine and Donepezil on Sleep and Attention and Gastrointestinal (GI) Tolerance in Patients With Mild to Moderate Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT00035204
- Acronym / sponsor ID
- CR002002
- Conditions
- Alzheimer Disease
- Keywords
- Donepezil, Alzheimer's, Dementia, Cognitive impairment, Aricept, Alzheimer's disease, Razadyne, Galantamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study completion
- May 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.
The purpose of this study is to evaluate the relative effects of galantamine compared to donepezil (both cholinesteraste inhibitors), on sleep, attention, and gastrointestinal tolerance in patients with Alzheimer's disease.
Detailed description
This is designed as a pilot (preliminary) study to evaluate the differences in effects on attention, sleep problems and gastrointestinal tolerance associated with Alzheimer's Disease with two different drugs at two different doses. Patients must have mild to moderate Alzheimer's Disease based on the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria and a Mini-Mental State Examination (MMSE) score of 10 to 24. The trial will consist of a 2-week run-in phase, an 8-week assessment phase, and an extension phase of variable length (6 weeks to 54 weeks). During the study, patients will be randomized (assigned by chance) to receive either galantamine or donepezil. Galantamine will be given by mouth 4mg twice daily for Weeks 1-4 and then 8mg twice daily for Weeks 5-8 and beyond (for participants in the extension). The patients on donezepil will receive 5mg by mouth at bedtime for Weeks 1-4 and then 10mg at bedtime for Weeks 5-8 and beyond. Placebo tablets will be given so that each patient takes two capsules per dose in order to conceal the identity of the drugs. Neither the patient nor the physician will know which drug the patient is receiving. Drug effectiveness will be measured by change in overall functioning of the patient shown by the Clinician's Interview-Based Impression of Change Plus Family Input (CIBIC-Plus). Other tests to evaluate whether the drug is effective will include the change in results of attention tests (Simple Reaction Time [SRT], Choice Reaction Time [CRT], Verbal Series Attention Test [VSAT], and Stroop Test), and in sleep pattern tests (tests that measure movements during sleep [Actiwatch] and patterns of sleep such as the caregiver-completed Pittsburgh Sleep Quality Index [PSQI] and the Circadian Sleep Inventory for Normal and Pathological States [CSINAPS]). Measures of quality of life will include the Alzheimer's Disease Related Quality of Life Scale (ADRQL) and the caregiver-completed Allocation of Caregiver Time Survey (ACTS) and SF-12 Quality of Life Survey. Safety assessment and gastrointestinal tolerability will be based on recording the number and severity of unexpected and undesirable events as well as physical examination and vital signs. The exploratory study hypotheses are that galantamine will be superior to donezepil in improving attention, sleep patterns, and quality of life in patients with mild-to-moderate Alzheimer's disease and that it will be well tolerated by patients.
Patients will receive either galantamine 4mg twice daily by mouth or donepezil 5mg at bedtime . Then, either galantamine 8mg twice daily by mouth or donezepil 10 mg at bedtime by mouth (with placebo dose); the doses are continued into the double-blind extension phase (6 to 54 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or post-menopausal female out-patients diagnosed with Alzheimer's disease
- Patients should have mild to moderate dementia as evidenced by a Mini-Mental State Examination score of 10-24 inclusive at screening
- The patient must show a history of cognitive decline that has been gradual in onset and progressive over a period of at least six months
- There must be evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of the following five areas: orientation, judgement and problem solving, functioning in community affairs, functioning in home and hobbies, or functioning in personal care
- The caregiver resides with the patient and is able to speak with the investigative team about the patient's activities, medication use and adverse events. In addition, the caregiver will participate in assessment interviews and complete questionnaires for themselves and the patients. The caregiver will monitor their own sleep, the patient's sleep, and complete questionnaires regarding sleep patterns and care giving activities
Key exclusion criteria (4 listed)
- Neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease
- One of the following conditions possibly resulting in cognitive impairment: acute cerebral trauma or injuries secondary to chronic trauma, hypoxic cerebral damage, e.g., post resuscitation (cardiac arrest, post anesthesia, secondary to severe self-poisoning episode, or secondary to severe hypovolemia)
- Patients with the following medical conditions: any history of epilepsy or convulsions except for febrile convulsions during childhood, clinically significant: endocrine disease, metabolic disease, psychiatric disease, cardiovascular disease, peptic ulcer disease, hepatic disease, renal disease, pulmonary disturbances or urinary outflow obstruction
- Use of any agent for the treatment of dementia (approved, experimental or over the counter agents) including patients who have previously received tacrin, donepazil, metrifonate, rivastigmine tartrate, galantamine, or memantine for treatment of Alzheimer's disease
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
To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance
1 secondary outcome
To assess the tolerability, overall effect, quality of life and safety of galantamine compared with donepezil
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.
- Derived from this study: PubMed 33189083McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
- A double-blind, randomized pilot study to evaluate the effects of galantamine and donepezil on sleep and attention and gastrointestinal (GI) tolerance in patients with mild to moderate Alzheimer's disease (AD).Link 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 and 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 4 study testing galantamine in people with Alzheimer Disease, 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 5 inclusion and 4 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 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?
To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance. 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 NCT00035204, 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 8 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.