Skip to main content
Delfa

← Trials/Trial dossier/NCT00377715

CompletedPhase 2

Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

Phase 2, Double-Blind, Placebo-Controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

Medivation, Inc.

Asset

Dimebon

Listed sites

1

Recruiting sites

-

Enrollment

183

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseStudy partner/caregiver required

Primary endpoint

Alzheimer's Disease Assessment Scale - cognitive subscale

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDIM02
NCT IDNCT00377715

Timeline

Milestones

Study start2005-09 (month precision)
Primary completion2006-08actual (month precision)
Study first posted2006-09-18estimated
Last update posted2015-11-11estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Males or females greater than or equal to 50 years of age.

2. Diagnosis of Alzheimer's Disease according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) and Mini Mental State Exam between 10 and 24, inclusive and Modified Hachinski Ischemia Score less than or equal to 4.

3. Brain imaging such as MRI and/or CT within one year of enrollment.

4. Subjects must have a guardian or caregiver who assists the subject at least 5 days per week (at least 3 hours/day).

5. Subjects must be able to cooperate with drug administration (including the ability to ingest oral medications) and study procedures and abide by study restrictions.

6. Subjects must have at least 6 years of prior education and should have previously (in pre-Alzheimer's condition) been capable of reading, writing and communicating effectively with others.

7. Subjects must be willing and able to give informed consent or have a mentally competent legal representative authorized to provide informed consent on their behalf.

8. Residence in an assisted care facility is allowed if subject is living independently

Exclusion criteria

1. Major structural brain disease

2. Major medical illness or unstable medical condition within 6 months of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions.

3. Residence in a nursing home or assisted care facility that provides the subject with 24-hour care and supervision.

4. Women who are pregnant, nursing, or if of child-bearing potential not using a medically accepted, highly effective method of birth control.

5. Active alcohol dependence or drug abuse.

6. Use of the following medications within 60 days prior to enrollment:cognition enhancing agents, narcotic analgesics, low potency neuroleptics, antihypertensive agents with frequent Central Nervous System (CNS) side effects, anti-Parkinsonian medications, medications with central anticholinergic activity, medications for epilepsy, lithium.

7. Participation in an investigational drug or device study within 30 days prior to study entry, or 60 days prior to study entry if the investigational drug study involved therapy for Alzheimer's Disease.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
2
Other clinical outcomes
1
Other (unclassified)
1

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Safety Assessed By Number of Participants With Adverse Events

Time frame:26 weeks

event count, event

Secondary/protocol endpoint

Pharmacokinetic (PK) parameter of Dimebon: Cmax

Time frame:Week 1, 2, 6, 12, 18, 24. Blood PK samples will be obtained pre-dose and 1 hour post-dose for each timepoint.

concentration, descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Clinical Global Impression of Change

Time frame:26 weeks

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale - cognitive subscale

Time frame:26 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.