To evaluate the long-term safety and tolerability of Dimebon in AD patients who have successfully completed 26 weeks of blinded treatment in the CONNECTION Study (DIM14) (hereafter referred to as *CONNECTION*).
ID
Source
Brief title
Condition
- Cranial nerve disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety Outcomes
The following assessments will be performed to monitor safety during the
study:
* Adverse events will be recorded at each visit;
* Vital signs will be monitored at each clinic visit;
* Physical examinations will be performed at Week 26 in the CONNECTION Study
(DIM14). During this CONNECTION PLUS Extension study, physical examinations
will be performed at routine quarterly intervals, at the End of Study and (if
applicable) Early Termination visit, as well as required for evaluation of
interval actual or potential adverse events;
* Clinical laboratory testing;
* ECG monitoring.
Efficacy Outcomes
The following assessment will be performed to evaluate efficacy during the
study: ADAS-cog, CIBIC-plus, MMSE, ADCS-ADL, NPI, and the RUD Lite.
Secondary outcome
N/A
Background summary
Alzheimer*s Disease (AD) is a progressive and fatal neurodegenerative disorder
manifested by persistent deterioration of memory and cognitive functions,
progressive impairment of activities of daily living, and a variety of
neuropsychiatric symptoms and behavioral disturbances.
The classic clinical features of AD are an amnestic type of memory impairment,
deterioration of language, and visuospatial deficits. Motor and sensory
abnormalities, gait disturbances, and seizures are generally believed to be
uncommon until the late phases of the disease. Death, most often from
complications of immobility such as pneumonia or pulmonary embolism, usually
ensues within five to nine years after diagnosis. This progressive and fatal
brain disease is projected to affect an estimated 5.2 million Americans of all
ages in 2008. AD is the seventh-leading cause of death for people of all ages
and it is the fifth-leading cause of death for people age 65 and over.
Approximately 26 million people worldwide suffer from AD.
Study objective
To evaluate the long-term safety and tolerability of Dimebon in AD patients who
have successfully completed 26 weeks of blinded treatment in the CONNECTION
Study (DIM14) (hereafter referred to as *CONNECTION*).
Study design
This study is an open-label extension study of one dose and regimen of oral
Dimebon (20 mg three times per day [TID]), administered to patients with AD who
have successfully completed 26 weeks of blinded treatment in the CONNECTION
Study (DIM14). Up to approximately 525 patients (the randomization cohort
anticipated for CONNECTION) will be offered participation in this extension
study. All patients will receive Dimebon 10 mg TID for the first seven days of
therapy, before titration up to Dimebon 20 mg TID through marketing
authorization in their respective countries.
Throughout the study, safety and tolerability will be assessed by recording of
adverse events, monitoring of vital signs and physical examinations, safety
laboratory evaluations, and 12-lead electrocardiograms (ECG).
Patients should have a caregiver who assists the patient at least five days per
week for at least three hours per day as in CONNECTION. Every effort should be
made to retain the same caregiver as from the preceding study.Efficacy
assessments including the ADAS-cog, CIBIC-plus, MMSE, ADCS-ADL, NPI, and the
RUD Lite will be performed at the Week 26 visit of the CONNECTION Study
(DIM14), and at Weeks 39, 52, 65, and 78. Every effort will be made to retain
the same raters for this extension study. The raters who administered these
scales in the CONNECTION Study (DIM14) will continue to administer the same
scales during CONNECTION PLUS. The independent rater who administered the
CIBIC-plus in the CONNECTION Study (DIM14) should continue to administer this
scale during CONNECTION PLUS.
Intervention
Patients will receive Dimebon 10 mg TID for the first seven days of therapy,
before titration up to Dimebon 20 mg TID for the remainder of the treatment
period.
Study burden and risks
Occasionally Dimebon can cause dry mouth, drowsiness, headache, inability to
sleep or interrupted sleep, depressed mood, or irritability. In addition, there
is always the risk of unknown side effects occurring.
During the study, blood samples will be taken for testing. The risks of giving
blood include temporary discomfort from the needle in the arm, bruising,
swelling at the needle site, or (rarely) infection.
It is possible that Dimebon may reduce symptoms of Alzheimer*s disease, but
there is no guarantee. The results of the study may help doctors to understand
Dimebon and Alzheimer*s disease.
201 Spear Street
CA 94105 San Francisco
United States
201 Spear Street
CA 94105 San Francisco
United States
Listed location countries
Age
Inclusion criteria
Patients eligible to participate in this CONNECTION PLUS Study (DIM14 Extension) are those who:
1. Have successfully completed 26 weeks of blinded treatment with available Week 26 efficacy assessment data (ADAS-cog, Clinician*s Interview Based Impression of Severity (CIBIS)/CIBIC-plus, MMSE, ADCS-ADL, NPI, and the RUD Lite) in the CONNECTION Study; at a minimum, the Week 26 ADAS-cog data must be available;
2. Are willing and able to give informed consent. If the patient is not competent, a legally-acceptable representative must provide informed consent on their behalf, and the patient should provide assent;
3. Are able to cooperate with study drug administration and safety assessments;
4. Ideally have a caregiver who assists the patient at least five days per week for at least three hours per day and has intimate knowledge of the patient*s cognitive, functional, and emotional states, and of the patient*s personal care. At a minimum, the caregiver must reliably report any adverse events the patient experiences;
5. If female, must be surgically sterile or postmenopausal (for at least two years) or agree to use double-barrier method of birth control;
6. If male, must agree to utilize double-barrier methods of birth control during the study and for at least 30 days following the last dose of study drug. The double-barrier method includes two of the following forms of contraception: condom, contraceptive sponge, diaphragm, or cervical ring with spermicidal gel or foam.
Exclusion criteria
Patients NOT eligible to participate in this CONNECTION PLUS Study (DIM14 Extension) are those who:
1. Have any major medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information;
2. Are pregnant or lactating females;
3. Plan to use bupropion, clozapine, or non-selective antihistamines during this extension trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-006352-22-NL |
| CCMO | NL26760.029.09 |