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

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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

NCT00104273•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age range: Adult patients, 45 to 90 years of age inclusive.
•2. 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.
•3. 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.
•4. Stable Aricept® dose of 10 mg daily for \>= 8 weeks.
•5. 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.
•6. Degree of dementia: MMSE score of \>= 15 and \<= 26 at Screening and Baseline.
•7. Race and ethnicity: any race and ethnic group.
•8. Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). Corrected vision and hearing sufficient for compliance with testing procedures.
•9. Clinical laboratory values must be within normal limits or, if abnormal, must be judged clinically insignificant by the Investigator.
•10. 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.
+3 more criteria

Exclusion Criteria

•1. 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).
•2. No reliable caregiver.
•3. 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.
•4. Psychiatric disorders affecting the ability to assess cognition such as schizophrenia, bipolar or unipolar depression, and sleep disorders.
•5. 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).
•6. Drug or alcohol abuse or dependence in \<= 5 years by DSM IV criteria.
•7. 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).
•8. 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.
•9. 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.
•10. 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.
+15 more criteria

Locations (58)

Collaborative Neuroscience Network

Huntsville, Alabama, United States

North Alabama Neuroscience Research

Huntsville, Alabama, United States

Northwest Neurospecialists, PLLC

Tucson, Arizona, United States

Clinical Study Centers, LLC

Little Rock, Arkansas, United States

East Bay Region Associates in Neurology

Berkeley, California, United States

Margolin Brain Institute

Fresno, California, United States

Collaborative Neuroscience Network

Garden Grove, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

Neurological Research Institute

Santa Monica, California, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Key Dates

Start Date

August 1, 2004

Primary Completion Date

March 1, 2007

Last Updated

July 15, 2009

Enrollment

376

ACTUAL participants

Conditions

DementiaAlzheimer's Disease

Interventions

Rasagiline

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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