A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.

NCT00309725 | Completed Phase 3

• 1 other identifier: CR012118
• Study Type: interventional
• Target: 139
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this trial was to investigate the effect of galantamine (an acetylcholinesterase inhibitor) on heart rate and PR interval (the time it takes for the heart's electrical impulse to get from the atria to the ventricles) during the administration of rapidly increasing doses and at the end of a 2-week treatment period with 32 mg per day in patients with Alzheimer's disease.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; cardiac arrhythmias

Outcome Measures

Primary Outcomes (1)

• Hourly mean heart rates and PR intervals during each of the 24-hour Holter monitoring periods; Twenty-four hour mean, minimum and maximum heart rates and PR intervals during each of the 24-hour Holter monitoring periods

Secondary Outcomes (1)

• Pharmacokinetics and other safety parameters including ECG parameters were other parameters of interest.

Interventions

galantamine DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) classification for probable Alzheimer's disease
• Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 11 to 24, inclusive, at baseline
• History of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months
• Evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of these five areas: orientation, judgment and problem-solving, functioning in community affairs, functioning in home and hobbies, and functioning in personal care
• Patients who live with or have regular daily visits from one or more responsible caregiver who are capable of assisting with the patient's medication, able to accompany the patient for assessments, and willing to provide information about the patient.On days that the patient was sent home with a Holter monitor, the caregiver was required to stay with the patient in the same household for the 24 hour duration of the cardiac assessment to ensure that the monitor lead placement remained intact. The caregiver was to be available the following day for the return of the Holter monitoring device
• Patient or patient's relative, guardian or legal representative have signed the informed consent.

You may not qualify if:

• Disorders such as Parkinson's disease, Pick's disease, or Huntington's chorea, Down's syndrome, Creutzfeldt-Jakob disease, Cushing's syndrome, or uncontrolled diabetes
• Cognitive impairment resulting from trauma, injury, or hypoxia
• Infection
• Mental retardation or dementia or clinically active cerebrovascular disease
• Current, clinically significant cardiovascular disease that would limit the patient's ability to complete a six-week trial.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.

  PMID: 39498781 DERIVED

Related Links

• A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease

MeSH Terms

Conditions

Alzheimer Disease; Arrhythmias, Cardiac

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Study Completion: October 1, 1999
• Last Updated: May 18, 2011

Record last verified: 2011-01