Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)
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
1 other identifier
interventional
376
4 countries
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 24, 2005
CompletedFirst Posted
Study publicly available on registry
February 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedJuly 15, 2009
April 1, 2008
2.6 years
February 24, 2005
July 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive Function
Secondary Outcomes (1)
Other Cognitive Assessments; Activities of Daily Living (ADLs); Functional Assessments; Safety; Tolerability.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.lead
- Eisai Inc.collaborator
Study Sites (58)
Collaborative Neuroscience Network
Huntsville, Alabama, 35801, United States
North Alabama Neuroscience Research
Huntsville, Alabama, 35801, United States
Northwest Neurospecialists, PLLC
Tucson, Arizona, 85741-3537, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
East Bay Region Associates in Neurology
Berkeley, California, 94705, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Collaborative Neuroscience Network
Garden Grove, California, 92845, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
North Broward Medical Center/Memory Disorder Center
West Palm Beach, Florida, 33409, United States
Emory University Wesley Woods Health Center
Altanta, Georgia, 30329, United States
Dekalb Neurology Associates, LLC
Decatur, Georgia, 30033, United States
Radiant Research
Chicago, Illinois, 60610, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46805, United States
Mid America Neuroscience Institute
Lenexa, Kansas, 66214, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Tulane University Health Sciences Center, Dept of Psychiatry and Neurology
New Orleans, Louisiana, 70112, United States
Department of Neurology - Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Northern Michigan Neurology
Traverse City, Michigan, 49684, United States
University Behavioral Healthcare Centre Department of Psychiatry
Piscataway, New Jersey, 08854, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Ohio State University, Department of Neurology
Columbus, Ohio, 43210, United States
Pahl Brain Associates
Oklahoma City, Oklahoma, 73118, United States
Medical University of South Carolina Alzheimer's Research and Clinical Programs
North Charleston, South Carolina, 29406-6076, United States
Department of Neurology Baylor College of Medicine
Houston, Texas, 77030-2744, United States
Premiere Research Institute
Houston, Texas, 77030, United States
University of Texas Mental Sciences Institute
Houston, Texas, 77030, United States
Peninsula Internal Medicine Associates
Gig Harbor, Washington, 98335, United States
Internal Medicine Northwest
Tacoma, Washington, 98405, United States
Ballarat Health Service - Queen Elizabeth Center
Ballarat, 3350, Australia
Aged Mental Health Research Unit - Kingston Centre
Cheltenham, 3192, Australia
Prince Charles Hospital - Dept. of Geriatrics
Chermside, QLD4032, Australia
Central Coast Neuroscience Research
East Gosford, NSW 2250, Australia
Heidelberg Repatriation Hospital
Heidelberg West, 3081, Australia
Hornsby Kur-ing-gai Hospital, Rehabilitation and Aged Care Service
Hornsby, 2076, Australia
St. George's Hospital
Kew, 3101, Australia
McCusker Foundation for Alzheimer's Disease Research
Nedlands, 6009, Australia
The Queen Elizabeth Hospital
Woodville, 5011, Australia
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7, Canada
Memory Disorder Clinic/Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
Dept. of Clinical Neurological Sciences - University of Western Ontario
London, Ontario, N6A 4V2, Canada
155974 Ont. Inc.
Peterborough, Ontario, K9H 2P4, Canada
Neurology Research Inc.
Toronto, Ontario, M3B 2W7, Canada
Bloemfontein Medi Clinic
Westdene, Bloemfontein, 9301, South Africa
Westdene Research Centre
Westdene, Bloemfontein, 9301, South Africa
Suite C, Black C
Sandton, Gauteng, 2196, South Africa
St. Augustine's Medical Mews.
Durban, 4001, South Africa
The Memory Centre
Johannesburg, 2197, South Africa
Dr. Felix Potocnik
Oakdale, 7530, South Africa
Panorama Medical Centre
Panorama, 7500, South Africa
Milpark Hospital
Parktown, 2193, South Africa
Crompton Medical Centre West
Pinetown, 3610, South Africa
Constantiaberg Medi Clinic
Plumstead, 7800, South Africa
Willows Medical Center
Pretoria, 0041, South Africa
Little Company of Mary Hospital
Pretoria, 0181, South Africa
Richard's Bay Trial Centre
Richard's Bay, 3900, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Timothy Hsu
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2005
First Posted
February 25, 2005
Study Start
August 1, 2004
Primary Completion
March 1, 2007
Last Updated
July 15, 2009
Record last verified: 2008-04