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DementiaPhase 2NCT00104273

Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)

A Phase 2 study testing Rasagiline in people with Dementia and Alzheimer's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 58 sites in 4 countries.

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

The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept. Read more about this study

Who is it for?
Ages 45 to 90 years
Conditions the study is for
Dementia, Alzheimer's Disease
What is being tested?
Rasagiline
How many people
376 participants
Where
58 sitesin 4 countries
Study dates
Aug 2004to Mar 2007
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 45 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range: Adult patients, 45 to 90 years of age inclusive.
  • Gender distribution: men and women. Women of child-bearing potential (< 1 year post-menopausal) must be practicing effective contraception and have a negative serum b-hCG at Screening.
  • Diagnosis: diagnostic evidence of probable Alzheimer's Disease consistent with DSM-IV 290.00 or 290.10 and NINCDS ADRDA criteria. This evidence may be compiled during Screening but must be fully documented in the patient's study file before the Baseline visit.
  • Stable Aricept® dose of 10 mg daily for >= 8 weeks.
  • Head image (CT or MRI): no evidence of focal disease to account for dementia on any head image (CT or MRI) obtained within 12 months prior to Baseline. If no such head image has been obtained prior to Screening, a head MRI will be obtained as part of the Screening evaluation; this MRI will also be used for Baseline volumetric analysis. The Baseline MRI obtained for volumetric analysis must also not show any evidence of focal disease to account for dementia.
  • Degree of dementia: MMSE score of >= 15 and <= 26 at Screening and Baseline.
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  • Race and ethnicity: any race and ethnic group.
  • Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). Corrected vision and hearing sufficient for compliance with testing procedures.
  • Clinical laboratory values must be within normal limits or, if abnormal, must be judged clinically insignificant by the Investigator.
  • Patients with vitamin B12 deficiency who are on a stable dose of medication for at least 12 weeks prior to Screening and who have normal serum vitamin B12 levels at Screening will be eligible. This stable dose of vitamin B12 must be maintained throughout the study. Subjects who might otherwise have been eligible can be re-screened for Vitamin B12 before Baseline.
  • Patients with hypothyroidism who are on a stable dose of medication for at least 12 weeks prior to Screening, have normal TSH and free T4 at screening, and are considered euthyroid will be eligible. This stable dose must be maintained throughout the study.
  • Patients must have a caregiver who has daily contact with the patient (e.g., an average of 10 or more hours per week), can observe for possible adverse events, and can accompany the patient to all visits.
  • Patients must be sufficiently fluent in English to be capable of reliably completing all study assessments.

Who cannot join

  • Patients taking (a) Aricept® doses other than 10 mg daily (or 10 mg for < 8 weeks); (b) other medications for Alzheimer's Disease except for stable, prescribed doses of 20 mg daily memantine for at least 4 weeks (preceded by titration to 20 mg daily).
  • No reliable caregiver.
  • Neurological disorders affecting cognition or the ability to assess it that are not associated with Alzheimer's Disease, such as Parkinson's disease, multi-infarct dementia, dementia due to cerebrovascular disease, Huntington's disease, Pick's disease, Creutzfeld-Jacob disease, Lewy Body disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis, as well as patients with human immunodeficiency virus (HIV) disease, neurosyphilis, or a history of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities.
  • Psychiatric disorders affecting the ability to assess cognition such as schizophrenia, bipolar or unipolar depression, and sleep disorders.
  • Dementia complicated by other organic disease or Alzheimer's Disease with delusions (DSM 290.20 or 290.12), delirium (DSM 290.30 or 290.11), or depression (DSM 290.21 or 290.13).
  • Drug or alcohol abuse or dependence in <= 5 years by DSM IV criteria.
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  • Any active or clinically significant conditions affecting absorption, distribution, or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose intolerance).
  • Uncontrolled hypertension (sitting systolic >= 160 mmHg and/or diastolic >= 95 mmHg) as assessed by the Investigator regardless of whether or not the patient is taking antihypertensive medications.
  • Insulin-dependent diabetes or diabetes not stabilized by diet and/or oral hypoglycemic agents as demonstrated by an Hb A1c of > 8.0% or a random serum glucose value of > 170 mg/dL.
  • Evidence of clinically significant, active gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease. Patients with right bundle branch block (complete or partial) may be included in the study, but patients with left bundle branch block are excluded.
  • History of malignant neoplasms (does not include basal or squamous cell carcinoma of the skin) treated within 5 years prior to study entry, current evidence of malignant neoplasm, recurrent, metastatic disease, or major risk factors for malignant melanoma (xeroderma pigmentosum, personal history of melanoma, more than 100 moles, and puva or other radiotherapy.
  • Donation of blood or blood products during 30 days prior to Screening or plans to donate blood while participating in the study or within 30 days after completion of the study.
  • Women who are pregnant or breast-feeding.
  • Patients and/or caregivers who are unwilling or unable to fulfill the requirements of the study.
  • Known hypersensitivity to cholinesterase inhibitors or MAO or MAO-B inhibitors.
  • Use of any unapproved prior or concomitant medications, including:
  • Recent (<= 12 weeks) or concomitant use of other MAO inhibitors.
  • Recent (<= 6 weeks) or concomitant use of SSRIs. (SSRIs and tricyclic and tetracyclic antidepressants in low doses are permissible, as follows: citalopram <= 20 mg daily, escitalopram <= 10 mg daily, and sertraline 25-100 mg daily).
  • Recent (<= 1 week) or concomitant use of sympathomimetics (including ephedra supplements).
  • Recent (<= 1 week) or concomitant use of meperidine.
  • Recent (<= 1 week) or concomitant use of dextromethorphan.
  • Recent (<= 1 week) or concomitant use of gentamicin.
  • Any condition that would make the patient or the caregiver, in the opinion of the Investigator, unsuitable for the study.
  • Involvement in any other investigational trial in the preceding 3 months or likely involvement in any other investigational trial during the course of this study.
  • Contraindications to MRI scanning, including CNS aneurysm clips, implanted neural stimulators, implanted cardiac pacemakers or defibrillators, cochlear implants, metallic ocular foreign body, insulin pump, or metal shrapnel or bullet.

Trial locations and contacts

58 sites in 4 countries.

58 sites in 4 countries

United States31 sites

  • Emory University Wesley Woods Health Center

    Altanta, Georgia, 30329

  • East Bay Region Associates in Neurology

    Berkeley, California, 94705

  • Department of Neurology - Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Radiant Research

    Chicago, Illinois, 60610

  • Ohio State University, Department of Neurology

    Columbus, Ohio, 43210

  • Dekalb Neurology Associates, LLC

    Decatur, Georgia, 30033

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • Odyssey Research

    Fargo, North Dakota, 58104

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • Margolin Brain Institute

    Fresno, California, 93720

  • Collaborative Neuroscience Network

    Garden Grove, California, 92845

  • Peninsula Internal Medicine Associates

    Gig Harbor, Washington, 98335

  • Department of Neurology Baylor College of Medicine

    Houston, Texas, 77030-2744

  • Premiere Research Institute

    Houston, Texas, 77030

  • University of Texas Mental Sciences Institute

    Houston, Texas, 77030

  • Collaborative Neuroscience Network

    Huntsville, Alabama, 35801

  • North Alabama Neuroscience Research

    Huntsville, Alabama, 35801

  • Mid America Neuroscience Institute

    Lenexa, Kansas, 66214

  • Clinical Study Centers, LLC

    Little Rock, Arkansas, 72205

  • Tulane University Health Sciences Center, Dept of Psychiatry and Neurology

    New Orleans, Louisiana, 70112

  • Medical University of South Carolina Alzheimer's Research and Clinical Programs

    North Charleston, South Carolina, 29406-6076

  • Pahl Brain Associates

    Oklahoma City, Oklahoma, 73118

  • Four Rivers Clinical Research

    Paducah, Kentucky, 42003

  • University Behavioral Healthcare Centre Department of Psychiatry

    Piscataway, New Jersey, 08854

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Internal Medicine Northwest

    Tacoma, Washington, 98405

  • Northern Michigan Neurology

    Traverse City, Michigan, 49684

  • Northwest Neurospecialists, PLLC

    Tucson, Arizona, 85741-3537

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • North Broward Medical Center/Memory Disorder Center

    West Palm Beach, Florida, 33409

Other trials in United States

South Africa13 sites

  • St. Augustine's Medical Mews.

    Durban, 4001

  • The Memory Centre

    Johannesburg, 2197

  • Dr. Felix Potocnik

    Oakdale, 7530

  • Panorama Medical Centre

    Panorama, 7500

  • Milpark Hospital

    Parktown, 2193

  • Crompton Medical Centre West

    Pinetown, 3610

  • Constantiaberg Medi Clinic

    Plumstead, 7800

  • Willows Medical Center

    Pretoria, 0041

  • Little Company of Mary Hospital

    Pretoria, 0181

  • Richard's Bay Trial Centre

    Richard's Bay, 3900

  • Suite C, Black C

    Sandton, Gauteng, 2196

  • Bloemfontein Medi Clinic

    Westdene, Bloemfontein, 9301

  • Westdene Research Centre

    Westdene, Bloemfontein, 9301

Other trials in South Africa

Australia9 sites

  • Ballarat Health Service - Queen Elizabeth Center

    Ballarat, 3350

  • Aged Mental Health Research Unit - Kingston Centre

    Cheltenham, 3192

  • Prince Charles Hospital - Dept. of Geriatrics

    Chermside, QLD4032

  • Central Coast Neuroscience Research

    East Gosford, NSW 2250

  • Heidelberg Repatriation Hospital

    Heidelberg West, 3081

  • Hornsby Kur-ing-gai Hospital, Rehabilitation and Aged Care Service

    Hornsby, 2076

  • St. George's Hospital

    Kew, 3101

  • McCusker Foundation for Alzheimer's Disease Research

    Nedlands, 6009

  • The Queen Elizabeth Hospital

    Woodville, 5011

Other trials in Australia

Canada5 sites

  • Glenrose Rehabilitation Hospital

    Edmonton, Alberta, T5G 0B7

  • Dept. of Clinical Neurological Sciences - University of Western Ontario

    London, Ontario, N6A 4V2

  • 155974 Ont. Inc.

    Peterborough, Ontario, K9H 2P4

  • Neurology Research Inc.

    Toronto, Ontario, M3B 2W7

  • Memory Disorder Clinic/Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

About this study

Official title: A 1-Year, Double-Blind, Randomized, Placebo-Controlled, Study of Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Dementia of the Alzheimer's Type

The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.

Being tested
Rasagiline
Keywords
Dementia, Alzheimer's Disease
Medical subject headings
Dementia, Alzheimer Disease

What participants receive

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

  • RasagilineDrug

What is being measured

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

  1. Cognitive Function

Secondary outcomes (1)

  1. Other Cognitive Assessments; Activities of Daily Living (ADLs); Functional Assessments; Safety; Tolerability.

Timeline

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

  1. First posted25 Feb 2005 (estimated)
  2. Study startAug 2004
  3. Primary completionMar 2007

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
Who is masked
Participant, Investigator
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104273
Sponsor's protocol ID
TVP-1012-A001-201
Status last verified
Apr 2008
First submitted
24 Feb 2005
Last updated
15 Jul 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rasagiline in people with Dementia and Alzheimer's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 58 sites in 4 countries.

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 13 inclusion and 25 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 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, South Africa, Australia, Canada. 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?

Cognitive Function. 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 NCT00104273.

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 15 Jul 2009.

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