A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease

NCT00912288 | Terminated Phase 3 Results DMC

• 1 other identifier: B1451006
• Study Type: interventional
• Target: 86
• Locations: 8 countries
• Sites: 47

Brief Summary

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease moderate-to-severe memantine safety and efficacy

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26

  SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis(0-8), visuospatial ability(0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score = greater cognitive impairment.

  Baseline, Week 26

• Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26

  ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.

  Baseline, Week 26

Secondary Outcomes (8)

• Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26

  Baseline, Week 26

• Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI

  Week 26

• Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26

  Baseline, Week 26

• Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores

  Week 26

• Resource Utilization in Dementia-Lite Version (RUD-Lite)

  Baseline, Weeks 12, 18, 26

Study Arms (2)

Dimebon

EXPERIMENTAL

Drug: Dimebon 20 mg po TID

Placebo

PLACEBO COMPARATOR

Drug: Placebo po TID

Interventions

Dimebon 20 mg po TID DRUG

Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks

Also known as: PF-01913539, Latrepirdine Dihydrochloride

Dimebon

Placebo po TID DRUG

Placebo (matched to Dimebon) po for 26 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.
• Have a Mini-Mental State Exam between 5 and 14 inclusive.
• Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.
• Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.

You may not qualify if:

• Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.
• Dementia other than Alzheimers disease.
• Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.

Sponsors & Collaborators

• Pfizer: lead
• Medivation, Inc.: collaborator

Study Sites (47)

Pfizer Investigational Site

Phoenix, Arizona, 85006, United States

Location

Pfizer Investigational Site

Costa Mesa, California, 92626, United States

Location

Pfizer Investigational Site

Encino, California, 91316, United States

Location

Pfizer Investigational Site

Los Alamitos, California, 90720, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660-2452, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92663, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80218, United States

Location

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New Haven, Connecticut, 06510, United States

Location

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Brooksville, Florida, 34601, United States

Location

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Delray Beach, Florida, 33445, United States

Location

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West Palm Beach, Florida, 33407, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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Lexington, Kentucky, 40503, United States

Location

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Pittsfield, Massachusetts, 01201, United States

Location

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Princeton, New Jersey, 08540, United States

Location

Pfizer Investigational Site

Rochester, New York, 14620, United States

Location

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Syracuse, New York, 13210, United States

Location

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Norristown, Pennsylvania, 19401, United States

Location

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East Providence, Rhode Island, 02914, United States

Location

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Cordova, Tennessee, 38018, United States

Location

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Middleton, Wisconsin, 53562, United States

Location

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Winnipeg, Manitoba, R3M 0X9, Canada

Location

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Montreal, Quebec, H4H-1R3, Canada

Location

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Québec, Quebec, G2B 5S1, Canada

Location

Pfizer Investigational Site

Berlin, 13581, Germany

Location

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Bochum, 44892, Germany

Location

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Günzburg, 89312, Germany

Location

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Leipzig, 04107, Germany

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Mainz, 55131, Germany

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Mittweida, 09648, Germany

Location

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Budapest, 1083, Hungary

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Gyula, 5700, Hungary

Location

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Székesfehérvár, 8000, Hungary

Location

Pfizer Investigational Site

Amadora, 2700-276, Portugal

Location

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Coimbra, 3000-548, Portugal

Location

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Bratislava, 82007, Slovakia

Location

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Michalovce, 071 01, Slovakia

Location

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Rožňava, 04801, Slovakia

Location

Pfizer Investigational Site

Žilina, 01001, Slovakia

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08014, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08041, Spain

Location

Pfizer Investigational Site

Algorta, Getxo, Bilbao, 48993, Spain

Location

Pfizer Investigational Site

Salt, Girona, 17190, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41071, Spain

Location

Pfizer Investigational Site

Istanbul, 34390, Turkey (Türkiye)

Location

Pfizer Investigational Site

Kocaeli, 41400, Turkey (Türkiye)

Location

Pfizer Investigational Site

Samsun, 55139, Turkey (Türkiye)

Location

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

Results are not summarized because of early termination of the study due to modification in the development plan of the study medication following lack of demonstration of efficacy in the completed DIM14 CONNECTION (B1451002/NCT00675623) study.

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: June 1, 2009
• First Posted: June 3, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 2, 2012
• Results First Posted: October 2, 2012

Record last verified: 2012-08

Locations

ES (5); DE (6); PT (2); CA (3); HU (3); US (21); TU (3); SL (4)