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Alzheimer DiseasePhase 2NCT00165659

A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

A Phase 2 study testing DONEPEZIL HYDROCHLORIDE in people with Alzheimer Disease, run by Eisai Limited at 65 sites in Japan.

Completed

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

Official record
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Trial summary

To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus* and SIB** as the primary efficacy measures. Safety of E2020 will also be evaluated. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
DONEPEZIL HYDROCHLORIDE
How many people
Not given
Where
65 sitesJapan
Study dates
Nov 2002to May 2005
Phase
Phase 2
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
  • Adult, Older adult

Who may be able to join

  • Patients with diagnostics of Alzheimer's disease (AD) according to DSM-IV.
  • Patients with modified Hachinski Ischemic scale score of ≦6.
  • FAST score of ≧6 at baseline (4 weeks before starting study treatment).
  • MMSE score between 1 and 12 at baseline (4 weeks before starting study treatment).
  • Imaging diagnostics (CT, MRI, etc., within 24 months consistent with the diagnosis of AD without any other comorbid pathologies found. If a significant change in clinical status suggesting other types of dementia (except AD) is suspected between the final image diagnosis and the time of starting observation, the scan test should be repeated.
  • Patients who can comply with the requirements on concomitant drugs/therapies from the baseline phase or before.
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  • Patients aged 50 years or older.
  • Outpatients. Even in the case of an outpatient or a patient attending on the outpatient-visit basis from a nursing home facility, the caregiver must be a constant and reliable informant with minimum of 3 days per week direct contact with the patient (for at least 4 hours per day on waking hours). This contact is necessary to ensure accurate reporting of the patient's behavior and his/her ability to perform ADLs.
  • Patients who are expected to complete all procedures scheduled during the Screening and Baseline visit and who 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 treatment schedule.
  • Patients who can swallow tablets without pulverization.
  • Patients who are ambulatory at least aided (walker) and have vision and hearing necessary for compliance with testing procedures (eyeglasses and/or hearing aid permissible).
  • Patients whose representatives can sign the written informed consent.

Who cannot join

  • Patients with dementia other than AD.
  • Patient whose imaging test shows "circumscribed cerebral lesion or multiple infarcts" which is suspected to be the responsible cause of dementia (mixed-type dementia)
  • Patients with other types of dementia
  • Patients with a current DSM-IV diagnosis of major depressive disorder or any current serious psychiatric diagnosis othe than AD.
  • Patients without a reliable caregiver.
  • Patients who are expected to enter a nursing home facility within 6 months after starting study treatment (excluding a transient entry).
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  • Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of study drugs (e.g., inflammatory bowel disease, gastric or duodenal ulcers, or severe lactose intolerance).
  • Patients with a known hypersensitivity to a component of donepezil hydrochloride preparation or piperidine derivatives.
  • Patients complicated with a severe gastrointestinal, hepatic, renal, endocrine, or cardiovascular system disease (e.g., sick sinus syndrome, intraarterial and supraventricular conduction disorder, etc.).
  • Patients with a history of severe bronchial asthma or obstructive pulmonary disease.
  • Patients with a severe extrapyramidal disease (Parkinson's disease, Parkinson's syndrome, etc.).
  • Patients with diabetes mellitus with uncontrolled blood glucose levels (HbAlc of ≧10%).
  • Hypertension patients with uncontrolled blood pressure (diastolic blood pressure of ≧95 mmHg).
  • Patients with uncontrolled thyroid dysfunction.
  • Patients with a history of seizure or convulsion within the previous 3 months (obtaining informed consent).
  • Patients with a known or suspected history of alcohoism or drug dependence within the recent 10 years.
  • Patients with malignant tumors.
  • Women of pregnant, possibly pregnant, or lactating.
  • Patients who have participated in another clinical study within the recent 3 months (before giving consent).
  • Any other patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

Japan65 sites

  • Study site

    Aio, Hyōgo, 678-0081

  • Study site

    Akita, Akita, 010-0146

  • Study site

    Akita, Akita, 010-0874

  • Study site

    Asago, Hyōgo, 679-3423

  • Study site

    Asahikawa, Hokkaido-prefecture, 078-8208

  • Study site

    Chita, Aichi-ken, 470-3411

  • Study site

    Chiyoda-ku, Tokyo, 101-0024

  • Study site

    Daisen, Akita, 019-2413

  • Study site

    Fujioka, Gunma, 375-0017

  • Study site

    Fukui-shi, Fukui, 910-0046

  • Study site

    Fukuoka, Fukuoka, 811-1122

  • Study site

    Fukuoka, Fukuoka, 813-0025

  • Study site

    Fukuoka, Fukuoka, 814-0133

  • Study site

    Fukuoka, Fukuoka, 819-0165

  • Study site

    Fukushima, Fukushima, 960-1247

  • Study site

    Gobō, Wakayama, 644-0002

  • Study site

    Hachiōji, Tokyo, 193-0944

  • Study site

    Higashimurayama, Tokyo, 189-0002

  • Study site

    Hiroshima, Hiroshima, 730-0011

  • Study site

    Hiroshima, Hiroshima, 734-0037

  • Study site

    Hōfu, Yamaguchi, 747-0065

  • Study site

    Itabashi-ku, Tokyo, 173-0015

  • Study site

    Izumo, Shimane, 693-0021

  • Study site

    Jōetsu, Niigata, 949-3116

  • Study site

    Kako, Hyōgo, 675-1114

  • Study site

    Kanazawa, Ishikawa-ken, 920-0934

  • Study site

    Kashihara, Nara, 634-0813

  • Study site

    Kashiwa, Chiba, 277-0004

  • Study site

    Kashiwazaki, Niigata, 945-1114

  • Study site

    Kawachi, Tochigi, 329-0431

  • Study site

    Kawasaki, Kanagawa, 211-0063

  • Study site

    Kawasaki, Kanagawa, 216-0015

  • Study site

    Kitakyushu, Fukuoka, 802-0978

  • Study site

    Kobe, Hyōgo, 650-0017

  • Study site

    Kobe, Hyōgo, 653-0013

  • Study site

    Kochi, Kochi, 780-0842

  • Study site

    Kodaira, Tokyo, 187-0031

  • Study site

    Kōriyama, Fukushima, 963-1309

  • Study site

    Kyoto, Kyoto, 600-8212

  • Study site

    Kyoto, Kyoto, 607-8064

  • Study site

    Machida, Tokyo, 194-0023

  • Study site

    Moriguchi, Osaka, 570-0074

  • Study site

    Nagasaki, Nagasaki, 850-0841

  • Study site

    Nagasaki, Nagasaki, 852-8061

  • Study site

    Nagoya, Aichi-ken, 466-0065

  • Study site

    Nanto, Toyama, 939-1851

  • Study site

    Neyagawa, Osaka, 572-0801

  • Study site

    Numata, Gunma, 378-0014

  • Study site

    Osaka, Osaka, 540-0006

  • Study site

    Osaka, Osaka, 545-0051

  • Study site

    Osaka, Osaka, 558-0056

  • Study site

    Ōtake, Hiroshima, 739-0651

  • Study site

    Sagamihara, Kanagawa, 228-0815

  • Study site

    Saitama, Saitama, 338-0003

  • Study site

    Sasebo, Nagasaki, 857-0022

  • Study site

    Shimotsuga, Tochigi, 321-0207

  • Study site

    Shinjuku-ku, Tokyo, 160-0023

  • Study site

    Shizuoka, Shizuoka, 424-0911

  • Study site

    Suita, Osaka, 565-0874

  • Study site

    Takatsuki, Osaka, 569-1041

  • Study site

    Toyohashi, Aichi-ken, 441-8124

  • Study site

    Tsuchiura, Ibaraki, 300-0053

  • Study site

    Tsukuba, Ibaraki, 305-0005

  • Study site

    Tsukubo, Okayama-ken, 701-0304

  • Study site

    Wakayama, Wakayama, 640-8435

Other trials in Japan

About this study

To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus* and SIB** as the primary efficacy measures. Safety of E2020 will also be evaluated.

(*for overall evalution of clinical symtoms) (**for cognitive function test)

Being tested
DONEPEZIL HYDROCHLORIDE
Medical subject headings
Alzheimer Disease

What participants receive

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

  • DONEPEZIL HYDROCHLORIDEDrug

What is being measured

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

  1. Primary Outcomes: Efficacy:

  2. CIBIC plus*, SIB**

  3. (*for overall evalution of clinical symtoms)

  4. (**for cognitive function test)

  5. Safety:

  6. Adverse event, adverse drug reaction, vital sign, clinical laboratory parameter, electrocardiogram

Secondary outcomes (2)

  1. Efficacy

  2. Behave-AD, ADCS-ADL-sev

Timeline

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

  1. First posted14 Sep 2005 (estimated)
  2. Study startNov 2002
  3. Primary completionMay 2005

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00165659
Sponsor's protocol ID
E2020-J081-231
Status last verified
Jan 2010
First submitted
12 Sep 2005
Last updated
29 Jan 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DONEPEZIL HYDROCHLORIDE in people with Alzheimer Disease, run by Eisai Limited at 65 sites in Japan.

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 12 inclusion and 20 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 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Primary Outcomes: Efficacy:. The study lists 6 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 NCT00165659.

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 29 Jan 2010.

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Clinical Trial NCT00165659 | AzTrials