A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
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ClinicalTrials.gov Identifier: NCT00236431 |
Recruitment Status
:
Completed
First Posted
: October 12, 2005
Last Update Posted
: June 8, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dementia Alzheimer Disease | Drug: Galantamine hydrobromide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1063 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease |
Study Start Date : | May 2001 |
Actual Study Completion Date : | December 2003 |

- Memory and cognition (ADAS-COG/MCI and CDR-SB scores), global functional skills and overall severity of dementia (the CDR-SB and the overall Clinical Dementia Rating) measured at 12 and 24 months.
- Digit Symbol Coding and Alzheimer's Disease Cooperative Study-ADL scale (MCI version) at 12 and 24 months. Safety assessment (reports of adverse events, laboratory values, results of physical examinations, and electrocardiograms) throughout the study.

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical decline of cognitive ability consistent with mild cognitive impairment
- Delayed recall score <= 10 on a New York University paragraph recall test
- Sufficient visual, hearing and communication capabilities and be willing to complete serial standard tests of cognitive function
- Have a consistent informant to accompany them on scheduled visits
- Be able to read, write and fully understand the language of the cognitive scales used in the study
Exclusion Criteria:
- Neurodegenerative disorders such as Parkinson's disease
- Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary or metastatic cerebral neoplasia
- Epilepsy
- Significant psychiatric disease
- Peptic ulcer disease
- Clinically significant heart, lung, liver or kidney diseases
- Pregnant or nursing women or those without adequate contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236431
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00236431 History of Changes |
Other Study ID Numbers: |
CR002014 |
First Posted: | October 12, 2005 Key Record Dates |
Last Update Posted: | June 8, 2011 |
Last Verified: | November 2010 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Mild cognitive impairment Galantamine hydrobromide Memory disorders |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Cognitive Dysfunction Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |
Galantamine Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Nootropic Agents |