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Bridging Study With GSK239512 In Patients With Mild To Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

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Bridging Study With GSK239512 In Patients With Mild To Moderate Alzheimer's Disease

A Single Blind, Placebo-controlled, Randomised Study in Mild to Moderate Alzheimer's Disease Patients to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK239512, a Selective Histamine H3 Receptor Antagonist

NCT00675090•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a safety and tolerability study to investigate the effect of GSK239512 on mild to moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the most well tolerated dose in the patients.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects with a clinical diagnosis of probable Alzheimer's disease
•The subject has an MMSE score at screening of 12 to 26 for Part A and 16-26 for Part B.
•Age ≥ 50 and above.
•If female, the subject must be post-menopausal (i.e. 12 months without menstrual period) or surgically sterile.
•Male subjects must be willing to abstain from sexual intercourse with pregnant or lactating women; or be willing to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant, from the time of the first dose of GSK239512 until 84 days following completion of the study.
•The subject has the ability to comply with the study procedures.
•The subject has a permanent caregiver and is willing to attend all study visits for Parts A and B.
•The subject has provided full written informed consent prior to the performance of any protocol specific procedure, or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
•The caregiver has provided his / her written consent prior to the performance of any protocol specific procedure.

Exclusion Criteria

•In the opinion of the investigator, following review of CT/MRI scans in the past 12 months and completion of neurological review there could be other probable causes of dementia
•History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, or current depression (a score of ≥8 on the Cornell Scale for Depression in Dementia), or subjects with other psychiatric features in their AD which would in the opinion of the investigator, would increase risk to safety.
•History of significant sleep disturbance, for example, when it is associated with nocturnal wandering, nocturnal confusion / disorientation / agitation, which in the opinion of the investigator, may increase safety risk.
•History or presence of known or suspected seizures, unexplained significant loss of consciousness within last 6 months. Subjects who had febrile seizures in childhood may be included if these ceased by age 10 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications.
•History or presence of significant cardiovascular, gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
•History of alcohol or other substance abuse, according to the Diagnostic and Statistical Manual of Mental Disorders - Substance related disorders (DSM-IV) criteria.
•Clinically significant abnormalities in laboratory tests, including subjects with active liver disease or uncontrolled thyroid disease.
•Uncontrolled hypertension with systolic BP ≥160 and/or diastolic ≥95 mmHg. Subjects with controlled hypertension with systolic BP \< 160 mmHg and diastolic \<95 mmHg for at least 4 weeks are acceptable.
•Systolic BP \<100 mmHg and/or diastolic \<60 mmHg.
•Subjects with ECG criteria outside ranges specified in the protocol
+7 more criteria

Locations (8)

GSK Investigational Site

Randwick, New South Wales, Australia

GSK Investigational Site

Heidelberg Heights, Victoria, Australia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Cambridgeshire, Cambridgeshire, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Southall, United Kingdom

Key Dates

Start Date

February 21, 2008

Primary Completion Date

June 16, 2009

Completion Date

June 16, 2009

Last Updated

July 7, 2017

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

GSK239512

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

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Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bridging Study With GSK239512 In Patients With Mild To Moderate Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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