Phase
Condition
Memory Loss
Dementia
Alzheimer's Disease
Treatment
N/AClinical Study ID
Ages 55-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject and caregiver must voluntarily sign and date an informed consent. If thesubject does not have the capacity to provide informed consent, full informed consentmust be obtained from the subject's representative and assent must be obtained fromthe subject.
The subject is a male or female between the ages of 55 and 90 years, inclusive, atScreening Visit 1. Main Inclusion (Continued):
The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer'sDisease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.
The subject must be receiving a stable dose of an AChEI (donepezil or rivastigmine)for at least 90 days prior to Screening Visit 1.
The subject has a Mini-Mental Status Examination (MMSE) total score of 12 to 24,inclusive, at Screening Visit 1.
The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 atScreening Visit 1.
The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at ScreeningVisit 1.
With the exception of a diagnosis of mild-to-moderate Alzheimer's disease and thepresence of stable medical conditions, the subject is in general good health, basedupon the results of medical history, physical examination, vital signs, laboratoryprofile, and a 12-lead electrocardiogram (ECG).
The subject has an identified, reliable caregiver who will provide support and ensurecompliance with the study medication and procedures, and provide accurate informationabout the subject's status during the study.
Exclusion
Exclusion Criteria:
- The subject has taken galantamine or memantine within 60 days prior to Screening Visit
The subject has received excluded concomitant medications.
The subject has clinically significant abnormal laboratory values at Screening Visit 1as determined by the investigator.
The subject has a history of any significant neurologic disease other than Alzheimer'sdisease including Parkinson's disease, multi-infarct or vascular dementia,Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy,multiple sclerosis, any seizures, mental retardation or a history of significant headtrauma followed by persistent neurologic deficits or known structural brainabnormalities.
In the opinion of the investigator, the subject has any clinically significantuncontrolled medical or psychiatric illness.
Study Design
Study Description
Connect with a study center
Site Reference ID/Investigator# 71793
Gatineau, J9A 1K7
CanadaSite Not Available
Site Reference ID/Investigator# 71794
Montreal, H3T 1E2
CanadaSite Not Available
Site Reference ID/Investigator# 71798
Peterborough, K9H 2P4
CanadaSite Not Available
Site Reference ID/Investigator# 71795
Toronto, M3B 2S7
CanadaSite Not Available
Site Reference ID/Investigator# 71796
Verdun, H4H 1R3
CanadaSite Not Available
Site Reference ID/Investigator# 71573
Dijon Cedex, 21033
FranceSite Not Available
Site Reference ID/Investigator# 77833
Limoges Cedex, 87042
FranceSite Not Available
Site Reference ID/Investigator# 68706
Paris, 75013
FranceSite Not Available
Site Reference ID/Investigator# 68704
Paris Cedex 10, 75475
FranceSite Not Available
Site Reference ID/Investigator# 68705
Toulouse Cedex 9, 31059
FranceSite Not Available
Site Reference ID/Investigator# 68768
Berlin, 14050
GermanySite Not Available
Site Reference ID/Investigator# 68764
Freiburg, 79106
GermanySite Not Available
Site Reference ID/Investigator# 68767
Huettenberg, 35625
GermanySite Not Available
Site Reference ID/Investigator# 69960
Mittweida, 09648
GermanySite Not Available
Site Reference ID/Investigator# 68765
Munich, 81675
GermanySite Not Available
Site Reference ID/Investigator# 69959
Schwerin, 19053
GermanySite Not Available
Site Reference ID/Investigator# 68730
Athens, 115 21
GreeceSite Not Available
Site Reference ID/Investigator# 68732
Athens, 151 25
GreeceSite Not Available
Site Reference ID/Investigator# 68733
Athens, 15123
GreeceSite Not Available
Site Reference ID/Investigator# 68731
Haidari, Athens, 12462
GreeceSite Not Available
Site Reference ID/Investigator# 68729
Thessaloniki, 56403
GreeceSite Not Available
Site Reference ID/Investigator# 68735
Thessaloniki, 570 10
GreeceSite Not Available
Site Reference ID/Investigator# 67586
Belville, 7530
South AfricaSite Not Available
Site Reference ID/Investigator# 67582
Cape Town, 7405
South AfricaSite Not Available
Site Reference ID/Investigator# 67584
George, 6529
South AfricaSite Not Available
Site Reference ID/Investigator# 67585
Johannesburg, 2196
South AfricaSite Not Available
Site Reference ID/Investigator# 67583
Rosebank, 2196
South AfricaSite Not Available
Site Reference ID/Investigator# 67787
Bath, BA1 3NG
United KingdomSite Not Available
Site Reference ID/Investigator# 67784
Glasgow, G20 0XA
United KingdomSite Not Available
Site Reference ID/Investigator# 67786
London, TW8 8DS
United KingdomSite Not Available
Site Reference ID/Investigator# 67785
Manchester, M8 5RB
United KingdomSite Not Available
Site Reference ID/Investigator# 67783
Warrington, WA2 8WA
United KingdomSite Not Available
Site Reference ID/Investigator# 66528
Fresno, California 93720
United StatesSite Not Available
Site Reference ID/Investigator# 69602
Long Beach, California 90806
United StatesSite Not Available
Site Reference ID/Investigator# 66527
San Francisco, California 94109-4841
United StatesSite Not Available
Site Reference ID/Investigator# 66530
Hamden, Connecticut 06518
United StatesSite Not Available
Site Reference ID/Investigator# 66522
Delray Beach, Florida 33445
United StatesSite Not Available
Site Reference ID/Investigator# 66524
Orlando, Florida 32806
United StatesSite Not Available
Site Reference ID/Investigator# 66531
Tampa, Florida 33613
United StatesSite Not Available
Site Reference ID/Investigator# 66529
West Palm Beach, Florida 33407
United StatesSite Not Available
Site Reference ID/Investigator# 66526
Elk Grove Village, Illinois 60007
United StatesSite Not Available
Site Reference ID/Investigator# 66525
Staten Island, New York 10312
United StatesSite Not Available
Site Reference ID/Investigator# 66523
Bennington, Vermont 05201
United StatesSite Not Available

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