Alzheimer's DiseasePhase 4NCT00142324
CALM-AD
A Phase 4 study testing Donepezil in people with Alzheimer's Disease, run by Institute of Psychiatry, London at 8 sites in United Kingdom.
Trial summary
Primary Aim To determine whether; Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment Secondary Aims To determine whether; Donepezil has a significant positive or negative… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Donepezil
- How many people
- 190 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Nov 2003to Dec 2005
- 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
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: a diagnosis of dementia consistent with Diagnostic and Statistical Manual of Mental Health Disorders, revised 3rd edition (DSM-III-R) (APA, 1987) National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) diagnostic criteria for probably or possible AD (MKhann et al, 1984) (Appendix 6) clinically significant agitation (defined as causing distress to patient and at least moderate management problems for carers on at least two days per week for a two week period, together with a Cohen Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield, 1986) (Appendix 11 A) score >39 age >39 years resident in care facility or community living with a carer not receiving treatment with neuroleptics or cholinesterase inhibitors currently or in the past four weeks and responsible clinician not considering treatment with cholinesterase inhibitor for the next 16 weeks taking into account the clinical evidence base and NICE guideline (NICE, 2001) patient with capacity willing to consent to study or will to participate in study if lacking capacity carer with capacity willing to consent to study and in agreement for patient lacking capacity to participate if patient willing to participate
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Exclusion Criteria:known sensitivity to Donepezil severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations current evidence of delirium patient meets criteria for Probably Dementia with Lewy Bodies (McKeith et al, 1996) low probability of treatment compliance
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Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Queen Elizabeth Psychiatric Hospital
Birmingham, B15 2QZ
Department of Psychiatry for the Elderly, Leicester General Hospital
Leicester, LE5 4PW
Institute of Psychiatry, King's College, London
London, SE5 8AF
Old Age Psychiatry, Wythenshawe Hospital, Manchester
Manchester, M23 9LT
Institute for Ageing and Health, Newcastle General Hospital, Newcastle
Newcastle upon Tyne, NE4 6BE
Department of Psychiatry, Warneford Hospital, Oxford
Oxford, OX3 7JX
MARC, Moorgreen Hospital, Southamptom
Southampton, S030 3JB
Department of Old Age Psychiatry, Victoria Hospital, Swindon
Swindon, SN1 4HZ
About this study
Official title: A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia That is Unresponsive to a Psychological Intervention
Primary Aim
To determine whether;
- Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment
Secondary Aims
To determine whether;
- Donepezil has a significant positive or negative impact upon quality of life compared with placebo
- whether there is a significant difference between Donepezil and placebo with respect to cognitive performance
- the cost effectiveness of the pharmacological treatment for agitation
- Conditions
- Alzheimer's Disease
- Being tested
- Donepezil
- Keywords
- Dementia
- 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.
DonepezilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen Mansfield Agitation Inventory
Secondary outcomes (4)
Neuropsychiatric Inventory
Standardized Mini-Mental State Examination
Severe Impairment Battery
Clinical Global Impression of Severity/Change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startNov 2003
- Study completionDec 2005
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'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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 190 participants
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Alzheimer's Society
- Investigators
- Robert Howard, Principal investigator, Institute of Psychiatry, LondonPeter Bentham, Principal investigator, Queen Elizabeth Psychiatric Hospital, BirminghamRichard Brown, Principal investigator, Institute of Psychiatry, LondonRoger Bullock, Principal investigator, Kingshill Research Centre, Victoria Hospital, SwindonAlistair Burns, Principal investigator, Wythenshawe Hospital, ManchesterClive Holmes, Principal investigator, Moorgreen Hospital, SouthamptonRobin Jacoby, Principal investigator, Warneford Hospital, OxfordJames Lindesay, Principal investigator, Leicester General Hospital, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142324
- Sponsor's protocol ID
- ISRCTN62185868
- Status last verified
- Sep 2005
- First submitted
- 1 Sep 2005
- Last updated
- 14 Dec 2005
- Results posted
- No
Publications
Howard RJ, Juszczak E, Ballard CG, Bentham P, Brown RG, Bullock R, Burns AS, Holmes C, Jacoby R, Johnson T, Knapp M, Lindesay J, O'Brien JT, Wilcock G, Katona C, Jones RW, DeCesare J, Rodger M; CALM-AD Trial Group. Donepezil for the treatment of agitation in Alzheimer's disease. N Engl J Med. 2007 Oct 4;357(14):1382-92. doi: 10.1056/NEJMoa066583.
PubMed 17914039
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia That is Unresponsive to a Psychological Intervention
- ClinicalTrials.gov ID
- NCT00142324
- Acronym / sponsor ID
- ISRCTN62185868
- Conditions
- Alzheimer's Disease
- Keywords
- Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Alzheimer's Society
- Study start
- Nov 2003
- Study completion
- Dec 2005
- First posted
- 2 Sep 2005 (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.
Primary Aim
To determine whether;
- Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment
Secondary Aims
To determine whether;
- Donepezil has a significant positive or negative impact upon quality of life compared with placebo
- whether there is a significant difference between Donepezil and placebo with respect to cognitive performance
- the cost effectiveness of the pharmacological treatment for agitation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Donepezil | Drug | – |
Primary outcome
Cohen Mansfield Agitation Inventory
4 secondary outcomes
Neuropsychiatric Inventory
Standardized Mini-Mental State Examination
Severe Impairment Battery
Clinical Global Impression of Severity/Change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2005.
- Derived from this study: PubMed 17914039Howard RJ, Juszczak E, Ballard CG, Bentham P, Brown RG, Bullock R, Burns AS, Holmes C, Jacoby R, Johnson T, Knapp M, Lindesay J, O'Brien JT, Wilcock G, Katona C, Jones RW, DeCesare J, Rodger M; CALM-AD Trial Group. Donepezil for the treatment of agitation in Alzheimer's disease. N Engl J Med. 2007 Oct 4;357(14):1382-92. doi: 10.1056/NEJMoa066583.
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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.
Robert Howard principal investigator
Institute of Psychiatry, London
Peter Bentham principal investigator
Queen Elizabeth Psychiatric Hospital, Birmingham
Richard Brown principal investigator
Institute of Psychiatry, London
8 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 Donepezil in people with Alzheimer's Disease, run by Institute of Psychiatry, London at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 14 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. 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?
Results are not available in the source record.
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?
Cohen Mansfield Agitation Inventory. 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 NCT00142324, 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 14 Dec 2005.