Alzheimer's DiseasePhase 3CONNECTIONNCT00675623
A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease
A Phase 3 study testing Dimebon in people with Alzheimer's Disease, run by Medivation, Inc. at 28 sites in United States.
Trial summary
The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Dimebon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 598 participants
- Where
- 28 sitesUnited States
- Study dates
- May 2008to Dec 2009
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-to-Moderate Alzheimer's disease
- Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
- MMSE score 10-24 inclusive
- Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD
- Caregiver who cares for the patient at least 5 days per week
Who cannot join
- Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days
- Other causes of dementia
- Other primary psychiatric or neurological disorders
- Unstable medical illnesses or significant hepatic or renal disease
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Ann Arbor, Michigan
Study site
Austin, Texas
Study site
Brooklyn, New York
Study site
Cedarhurst, New York, 11516
Study site
Centerville, Ohio
Study site
Costa Mesa, California
Study site
Fresno, California, 93720
Study site
Hallandale, Florida, 33009
Study site
Hamden, Connecticut
Study site
Hialeah, Florida
Study site
Indianapolis, Indiana, 46260
Study site
Miami, Florida, 33137
Study site
Middleton, Wisconsin, 53562
Study site
Morganton, North Carolina, 28655
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Newton, Massachusetts, 02459
Study site
Norristown, Pennsylvania
Study site
North Miami, Florida, 33161
Study site
Norwalk, Connecticut
Study site
Paducah, Kentucky, 42003
Study site
Phoenix, Arizona, 85004
Study site
Rancho Mirage, California
Study site
Rochester, New York, 14620
Study site
St Louis, Missouri, 63044
Study site
Staten Island, New York
Study site
Sunrise, Florida, 33351
Study site
West Palm Beach, Florida, 33407
About this study
Official title: A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)
The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).
Read the detailed description
This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.
The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.
- Conditions
- Alzheimer's Disease
- Being tested
- Dimebon, Placebo
- Keywords
- Alzheimer's disease, clinical trial, memory loss, mitochondria,, investigational drug, neurodegenerative disease, dementia
- Medical subject headings
- Alzheimer Disease, Memory Disorders, Neurodegenerative Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimebonDrug
Dimebon, 5 mg orally three times daily for six months
DimebonDrug
Dimebon 20 mg orally three times daily for six months
PlaceboDrug
Placebo three times daily for six months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dimebon, 5 mg orally three times daily Receives: Drug: Dimebon |
| B | Experimental | Dimebon 20 mg orally three times daily Receives: Drug: Dimebon |
| C | Placebo comparator | Placebo orally three times daily for six months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog).
Measured: Week 26
To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus).
Measured: Week 26
Secondary outcomes (2)
To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).
Measured: Week 26
To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI).
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynn Seely, MD, Study director, Medivation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675623
- Sponsor's protocol ID
- CONNECTION
- Other IDs
- DIM14
- Acronym
- CONNECTION
- Status last verified
- Sep 2016
- First submitted
- 7 May 2008
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)
- ClinicalTrials.gov ID
- NCT00675623
- Acronym / sponsor ID
- CONNECTION / CONNECTION
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, clinical trial, memory loss, mitochondria,, investigational drug, neurodegenerative disease, dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).
Detailed description
This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.
The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: DimebonDimebon, 5 mg orally three times daily |
| B | Experimental | Drug: DimebonDimebon 20 mg orally three times daily |
| C | Placebo comparator | Drug: PlaceboPlacebo orally three times daily for six months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mild-to-Moderate Alzheimer's disease
- Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
- MMSE score 10-24 inclusive
- Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD
- Caregiver who cares for the patient at least 5 days per week
Key exclusion criteria (4 listed)
- Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days
- Other causes of dementia
- Other primary psychiatric or neurological disorders
- Unstable medical illnesses or significant hepatic or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DimebonDimebon, 5 mg orally three times daily for six months | Drug | A |
| DimebonDimebon 20 mg orally three times daily for six months | Drug | B |
| PlaceboPlacebo three times daily for six months | Drug | C |
Primary outcome
To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog).
Time frame: Week 26
To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus).
Time frame: Week 26
2 secondary outcomes
To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).
Time frame: Week 26
To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI).
Time frame: Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Seely, MD study director
Medivation, Inc.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dimebon in people with Alzheimer's Disease, run by Medivation, Inc. at 28 sites in United States.
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 5 inclusion and 4 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). (time frame: Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2016.