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Severe Alzheimer's DiseasePhase 4NCT00711204

Evaluating The Impact Of Donepezil Hydrochloride (Aricept) On Behavioral And Psychological Symptoms In Patients With Severe Alzheimer's Disease

A Phase 4 study testing Donepezil Hydrochloride (Aricept) in people with Severe Alzheimer's Disease, run by Eisai Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A 12-week, multicenter, randomized, double-blind, placebo-controlled phase IV study. Approximately 200 subjects will be enrolled, half will receive active drug (donepezil hydrochloride) and half will receive matching placebo at approximately 50 research sites within the US, the European Union, South Africa and… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Severe Alzheimer's Disease
What is being tested?
Donepezil Hydrochloride (Aricept)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2008to Jun 2009
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range: Patients greater than 50 years.
  • Sex distribution: both men and women. Women must be two (2)-years post-menopausal or surgically sterile.
  • MMSE scores between 1 and 12 (inclusive).
  • Clinically significant behavioral pathology as measured by the Cornell Scale for Depression in Dementia(CSDD), defined as a total score on the CSDD of 5 or greater with at least one item rated 2 (severe) within the domains of Mood-Related Signs (Anxiety, Sadness, Lack of Reactivity, Irritability) or Behavioral Disturbances (Agitation, Retardation, Multiple Physical Complaints, Loss of Interest).
  • Diagnostic evidence of probable or possible Alzheimer's disease (DSM-IV and NINCDS/ADRDA) made or confirmed by the site physician at the time of the screening visit. This evidence must be fully documented in the patient's file prior to the baseline visit.
  • CT or MRI within the last 36 months consistent with a diagnosis of Alzheimer's disease without any other clinically significant comorbid pathologies found. A copy of the report will be required and should be appended to the case report form. If there has been a significant change in clinical status suggestive of stroke or other possible neurological disease with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated if considered appropriate by the investigator.
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  • Prior use of cholinesterase inhibitors (Aricept®, Exelon®, Cognex®, Reminyl/Razadyne®, metrifonate, physostigmine) and memantine is allowed, provided that the medication was discontinued at least 3 months prior to screening and that it was not discontinued for the purpose of enrolling the patient in the study.
  • Functional Assessment Staging (FAST) score >6a.
  • Patients residing in the community, assisted living facilities (ALF) or skilled nursing homes.
  • The patient must be expected to complete all procedures scheduled during the Screening and Baseline visits including all efficacy parameters. Patients must have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the medication schedule. For patients residing in assisted living facilities or skilled nursing homes, the reporting caregiver may be a professional staff member, provided he or she meets the criteria in number 11, and study visits may take place in the facility if the study site staff finds this preferable to facilitate the smooth conduct of the study.
  • The caregiver must be a constant and reliable informant with a minimum of three days per week direct contact with the patient (for at least 4 hours per day during waking hours). This contact is necessary to ensure accurate reporting of the patient's behavior.
  • Patients with stable Type I (Insulin-Dependent) or Type II diabetes are eligible provided they are monitored regularly prior to and during the study to ensure adequate glucose control (hemoglobin A1c <8%).
  • Clinical laboratory values within normal limits and within the sponsor's guidelines, or abnormalities considered not clinically significant by the investigator and sponsor.
  • Patients with controlled hypertension (sitting diastolic BP < 95 mmHg and/or sitting systolic BP <160 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study.
  • Patients with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening.
  • Patients with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months and have not had a seizure within the past 6 months.
  • Patients must be able to swallow tablet medication; no crushing of tablets is allowed.
  • Patients should be independent in ambulation or ambulatory-aided (i.e., walker, cane, or wheelchair); vision and hearing (eyeglasses and/or hearing aids permissible) should be sufficient for compliance with testing procedures.
  • Patients must be sufficiently proficient in the language in which the assessments are to be conducted.

Who cannot join

  • Age range: Patients less than 50 years.
  • MMSE score of <1 or >12.
  • FAST score of < 6a.
  • CSDD>18
  • Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance).
  • Patients with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors.
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  • Patients without a reliable caregiver, or patients or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study.
  • Patients with clinically significant obstructive pulmonary disease or asthma, untreated or not controlled by treatment within 3 months prior to screening.
  • Patient's with recent (< 2 years) hematologic/oncologic disorders (mild anemia allowed).
  • Evidence of active, clinically significant and unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
  • Patients with a current DSM-IV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than Alzheimer's disease (as per DSM-IV). Patients with CSDD scores >19 will be considered to have MDD and are excluded.
  • Patients with dementia complicated by other organic disease (DSM 290.30 or 290.11) are excluded; depressive symptoms and delusions are common in Alzheimer's disease, but patients with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded.
  • Patients with vascular dementia or dementia complicated by tertiary syphilis
  • Patients with a known or suspected history of alcoholism or drug abuse (within the past 10 years).
  • Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kettlie Joseph Daniels, M.D. Inc.

    Toledo, Ohio, 43609

Other trials in United States

About this study

Official title: A 12-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Impact Of Donepezil Hydrochloride (Aricept) On Behavioral And Psychological Symptoms In Patients With Severe Alzheimer's Disease

A 12-week, multicenter, randomized, double-blind, placebo-controlled phase IV study. Approximately 200 subjects will be enrolled, half will receive active drug (donepezil hydrochloride) and half will receive matching placebo at approximately 50 research sites within the US, the European Union, South Africa and Australia. Eligible subjects will reside at home, in an assisted living facility, or nursing homes age and will be 50 years or older, with a diagnosis of Alzheimer's disease in the severe stage. All subjects must start with 5mg a day (one 5 mg tablet of donepezil HCL or matching placebo). Dose will be increased to 10 mg a day (two tablets of 5 mg donepezil HCL or matching placebo) after 4 weeks. Dose may be decreased based on side effects. The primary efficacy measure will be the Cornell Scale for Depression in Dementia (CSDD). Secondary measures will include Functional Assessment Staging (FAST), Mini-Mental State Examination (MMSE), NPI-10 (Neuropsychiatric Inventory), DEMQOL Proxy ( Quality of Life). Blood levels of cytokines and safety will also be assessed.

Being tested
Donepezil Hydrochloride (Aricept)
Keywords
Severe, Alzheimer's Disease
Medical subject headings
Alzheimer Disease, Lymphoma, Follicular

What participants receive

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

  • Donepezil Hydrochloride (Aricept)Drug

    Also called Aricept

    5mg (or 10mg) tablet, once daily, with a full glass of water.

Study groups in NCT00711204
Study groupRoleWhat they receive
1Placebo comparatorNot described
Receives: Drug: Donepezil Hydrochloride (Aricept)
2Active comparatorNot described
Receives: Drug: Donepezil Hydrochloride (Aricept)

What is being measured

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

  1. CSDD (Cornell Scale for Depression in Dementia).

    Measured: Screening visit, Visit 1, 2, 3 and 4

Secondary outcomes (1)

  1. FAST (Functional Assessment Staging), NPI-10, MMSE (Mini Mental State Examination), DemQol (Dementia Quality of Life).

    Measured: Screening visit; visits 1-4.

Timeline

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

  1. First posted8 Jul 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2009

Why it stopped: No patients were enrolled in the study.

Resources

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
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711204
Sponsor's protocol ID
E2020-A001-417
Status last verified
Dec 2012
First submitted
21 Jan 2008
Last updated
10 Dec 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Donepezil Hydrochloride (Aricept) in people with Severe Alzheimer's Disease, run by Eisai Inc. at 1 site in United States.

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 19 inclusion and 15 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: withdrawn, as of the sponsor's last update on 10 Dec 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

CSDD (Cornell Scale for Depression in Dementia). (time frame: Screening visit, Visit 1, 2, 3 and 4). 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 NCT00711204.

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 10 Dec 2012.

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