A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

NCT00838110 | Completed Phase 3 Results DMC

• 1 other identifier: B1451027
• Study Type: interventional
• Target: 742
• Locations: 3 countries
• Sites: 118

Brief Summary

This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Dimebon; Safety; Tolerability

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1

  Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (\<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (\>=) 30 mmHg from baseline; absolute diastolic BP value: \<50 mmHg, maximum increase or decrease of \>=20 mmHg from baseline; absolute heart rate values: \>120 beats per minute (bpm).

  Baseline up to Week 30 (follow-up)

• Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2

  Abnormal clinically significant vital signs included absolute systolic BP values: \<90 mmHg, maximum increase or decrease of \>=30 mmHg from baseline; absolute diastolic BP values: \<50 mmHg, maximum increase or decrease of \>=20 mmHg from baseline; absolute heart rate values: \>120 bpm.

  Baseline up to Week 16 (follow-up)

• Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1

  Abnormal ECG findings included maximum value of \>=300 millisecond (msec), maximum increase of \>=25% for baseline value of \>200 msec and maximum increase of \>=50% for baseline value of \<=200 msec for PR interval (int); maximum value of \>=200 msec, maximum increase of \>=25% for baseline value of \>100 msec and maximum increase of \>=50% for baseline value of \<=100 msec for QRS interval; maximum value of \>=500 msec for QT interval; maximum value of 450 to \<480, 480 to \<500 and \>=500 msec, increase of \>=30 to \<60 and \>=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).

  Baseline up to Week 30 (follow-up)

• Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2

  Abnormal ECG findings included maximum value of \>=300 msec, maximum increase of \>=25% for baseline value of \>200 msec and maximum increase of \>=50% for baseline value of \<=200 msec for PR interval; maximum value of \>=200 msec, maximum increase of \>=25% for baseline value of \>100 msec and maximum increase of \>=50% for baseline value of \<=100 msec for QRS interval; maximum value of \>=500 msec for QT interval; maximum value of 450 to \<480, 480 to \<500 and \>=500 msec, increase of \>=30 to \<60 and \>=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).

  Baseline up to Week 16 (follow-up)

• Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1

  For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was \>=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH \>8 and specific gravity \<1.003 or \>1.030.

  Baseline up to Week 30 (follow-up)

• Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2

  For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was \>=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH \>8 and specific gravity \<1.003 or \>1.030.

  Baseline up to Week 16 (follow-up)

• Percentage of Participants With Adverse Events (AEs) in Cohort 1

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  Baseline up to Week 30 (follow-up)

• Percentage of Participants With Adverse Events (AEs) in Cohort 2

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  Baseline up to Week 16 (follow-up)

Study Arms (4)

Dimebon 20 mg TID (Cohort 1)

EXPERIMENTAL

Drug: Dimebon

Placebo TID (Cohort 1)

PLACEBO COMPARATOR

Drug: Placebo

Dimebon 20 mg TID (Cohort 2)

EXPERIMENTAL

Drug: Dimebon

Placebo TID (Cohort 2)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dimebon DRUG

10 mg TID for week 1 followed by 20 mg TID through Week 26

Dimebon 20 mg TID (Cohort 1)

Placebo DRUG

10 mg TID for week 1 followed by 20 mg TID through Week 26

Placebo TID (Cohort 1)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Alzheimer's Disease.
• MMSE 12-26 inclusive.
• If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
• If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

You may not qualify if:

• Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region \[e.g., thalamus, hippocampus\]).
• Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
• Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
• Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.

Sponsors & Collaborators

• Pfizer: lead
• Medivation, Inc.: collaborator

Study Sites (118)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

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Northport, Alabama, 35476, United States

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Little Rock, Arkansas, 72205, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92123, United States

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Santa Rosa, California, 95405, United States

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Pueblo, Colorado, 81001, United States

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Hockessin, Delaware, 19707, United States

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Bradenton, Florida, 34205, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33756, United States

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Daytona Beach, Florida, 32114, United States

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Daytona Beach, Florida, 32117, United States

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Destin, Florida, 32541, United States

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Fort Myers, Florida, 33912, United States

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Fort Walton Beach, Florida, 32547, United States

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Fruitland Park, Florida, 34731, United States

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Melbourne, Florida, 32901, United States

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Naples, Florida, 34102, United States

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Ocala, Florida, 34471, United States

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Ocala, Florida, 34474, United States

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Orlando, Florida, 32806, United States

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Plant City, Florida, 33563, United States

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Port Charlotte, Florida, 33952, United States

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Port Orange, Florida, 32127, United States

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St. Petersburg, Florida, 33709, United States

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St. Petersburg, Florida, 33713, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33629, United States

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Atlanta, Georgia, 30308, United States

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Burr Ridge, Illinois, 60527, United States

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Elk Grove Village, Illinois, 60007, United States

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Elkhart, Indiana, 46514, United States

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Evansville, Indiana, 47714, United States

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Fort Wayne, Indiana, 46805, United States

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Greenfield, Indiana, 46140-2834, United States

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Prairie Village, Kansas, 66206, United States

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Wichita, Kansas, 67207, United States

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Lake Charles, Louisiana, 70601, United States

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Shreveport, Louisiana, 71105, United States

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West Yarmouth, Massachusetts, 02763, United States

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Flowood, Mississippi, 39232, United States

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Olive Branch, Mississippi, 38654, United States

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Kansas City, Missouri, 64114, United States

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Springfield, Missouri, 65807, United States

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Great Falls, Montana, 59405, United States

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Eatontown, New Jersey, 07724, United States

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Oakhurst, New Jersey, 07755, United States

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Toms River, New Jersey, 08755, United States

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Albuquerque, New Mexico, 87109, United States

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Amherst, New York, 14226, United States

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Buffalo, New York, 14211, United States

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Buffalo, New York, 14215, United States

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Orchard Park, New York, 14127, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28211, United States

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Raleigh, North Carolina, 27607, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45227, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97210, United States

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Altoona, Pennsylvania, 16602, United States

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Beaver, Pennsylvania, 15009, United States

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Bridgeville, Pennsylvania, 15017, United States

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Grove City, Pennsylvania, 16127, United States

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Indiana, Pennsylvania, 15701, United States

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Norristown, Pennsylvania, 19401, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Scotland, Pennsylvania, 17254, United States

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Upper Saint Clair, Pennsylvania, 15241, United States

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Charleston, South Carolina, 29425, United States

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Greer, South Carolina, 29651, United States

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Murrells Inlet, South Carolina, 29576, United States

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North Charleston, South Carolina, 29406-6076, United States

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Orangeburg, South Carolina, 29118, United States

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Sioux Falls, South Dakota, 57105, United States

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Franklin, Tennessee, 37067, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37203, United States

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Carrollton, Texas, 75007, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76117, United States

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Grand Prairie, Texas, 75050, United States

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Houston, Texas, 77074, United States

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Lake Jackson, Texas, 77566, United States

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Williamsburg, Virginia, 23185, United States

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Kirkland, Washington, 98033, United States

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Spokane, Washington, 99216, United States

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Charleston, West Virginia, 25304, United States

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La Crosse, Wisconsin, 54650, United States

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Calgary, Alberta, T3C 3P1, Canada

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Medicine Hat, Alberta, T1B 4E7, Canada

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Surrey, British Columbia, V4A 2H9, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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Saint John, New Brunswick, E2L 3L6, Canada

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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

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Kentville, Nova Scotia, B4N 4K9, Canada

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Pictou, Nova Scotia, B0K 1H0, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Corunna, Ontario, N0N 1G0, Canada

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London, Ontario, N6A 4V2, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M6M 3Z5, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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L'Ancienne-Lorette, Quebec, G2E 2X1, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Québec, Quebec, G2B 5S1, Canada

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Saint-Jean-sur-Richelieu, Quebec, J2W 1J1, Canada

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Saint-Léonard, Quebec, H1S 3A9, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Cayey, PR, 00736, Puerto Rico

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Rio Piedras, PR, 00924, Puerto Rico

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San Juan, PR, 00907, Puerto Rico

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San Juan, PR, 00918, Puerto Rico

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Cidra, 00739, Puerto Rico

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

latrepirdine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This safety study did not specify primary or secondary outcome measures. Relevant summaries of all safety assessments are thus provided. Urine blood abnormalities seen are deemed due to interference with dipstick test by a metabolite of dimebon.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 6, 2018
• Results First Posted: February 8, 2013

Record last verified: 2018-11

Locations

CA (20); PR (5); US (93)