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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00104273




Registration number
NCT00104273
Ethics application status
Date submitted
24/02/2005
Date registered
25/02/2005
Date last updated
15/07/2009

Titles & IDs
Public title
Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)
Scientific 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
Secondary ID [1] 0 0
TVP-1012-A001-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rasagiline

Treatment: Drugs: Rasagiline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cognitive Function
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Other Cognitive Assessments; Activities of Daily Living (ADLs); Functional Assessments; Safety; Tolerability.
Timepoint [1] 0 0

Eligibility
Key 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.

11. 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.

12. 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.

13. Patients must be sufficiently fluent in English to be capable of reliably completing
all study assessments.
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

11. 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.

12. 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.

13. Women who are pregnant or breast-feeding.

14. Patients and/or caregivers who are unwilling or unable to fulfill the requirements of
the study.

15. Known hypersensitivity to cholinesterase inhibitors or MAO or MAO-B inhibitors.

16. 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.

17. Any condition that would make the patient or the caregiver, in the opinion of the
Investigator, unsuitable for the study.

18. 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.

19. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
376
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ballarat Health Service - Queen Elizabeth Center - Ballarat
Recruitment hospital [2] 0 0
Aged Mental Health Research Unit - Kingston Centre - Cheltenham
Recruitment hospital [3] 0 0
Prince Charles Hospital - Dept. of Geriatrics - Chermside
Recruitment hospital [4] 0 0
Central Coast Neuroscience Research - East Gosford
Recruitment hospital [5] 0 0
Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [6] 0 0
Hornsby Kur-ing-gai Hospital, Rehabilitation and Aged Care Service - Hornsby
Recruitment hospital [7] 0 0
St. George's Hospital - Kew
Recruitment hospital [8] 0 0
McCusker Foundation for Alzheimer's Disease Research - Nedlands
Recruitment hospital [9] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
3192 - Cheltenham
Recruitment postcode(s) [3] 0 0
QLD4032 - Chermside
Recruitment postcode(s) [4] 0 0
NSW 2250 - East Gosford
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [6] 0 0
2076 - Hornsby
Recruitment postcode(s) [7] 0 0
3101 - Kew
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
North Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Manitoba
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
South Africa
State/province [25] 0 0
Bloemfontein
Country [26] 0 0
South Africa
State/province [26] 0 0
Gauteng
Country [27] 0 0
South Africa
State/province [27] 0 0
Durban
Country [28] 0 0
South Africa
State/province [28] 0 0
Johannesburg
Country [29] 0 0
South Africa
State/province [29] 0 0
Oakdale
Country [30] 0 0
South Africa
State/province [30] 0 0
Panorama
Country [31] 0 0
South Africa
State/province [31] 0 0
Parktown
Country [32] 0 0
South Africa
State/province [32] 0 0
Pinetown
Country [33] 0 0
South Africa
State/province [33] 0 0
Plumstead
Country [34] 0 0
South Africa
State/province [34] 0 0
Pretoria
Country [35] 0 0
South Africa
State/province [35] 0 0
Richard's Bay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00104273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Timothy Hsu
Address 0 0
Eisai Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00104273