ELND005 in Patients With Mild to Moderate Alzheimer's Dis... | NCT00568776

NCT00568776

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Intervention Names
1	Placebo Comparator	Drug: Placebo Control
2	Active Comparator	Drug: ELND005
3	Active Comparator	Drug: ELND005
4	Active Comparator	Drug: ELND005

Name	Type	Description	Arm Group Labels	Other Names
Placebo Control	Drug	ELND005 matched placebo capsules for oral administration, bid for 78 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)	The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.	Baseline and 78 weeks
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)	The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.	Baseline and 78 weeks
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)	The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.	Baseline and 78 weeks
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)	The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.	Baseline and 78 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)	The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.	Baseline and 78 weeks

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Banner Alzheimer's Institute		Phoenix	Arizona	85006	United States
Sun Health Research Institute

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo BID	oral administration for 78 weeks
FG001	ELND005 250 mg BID	oral administration for 78 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG00083 subjectsOne randomized patient withdrew consent and did not receive placebo

FG00188 subjectsOne randomized patient withdrew consent and did not receive ELND005 250 mg BID

FG00289 subjects41 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.

FG00391 subjects42 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo BID	oral administration for 78 weeks
BG001	ELND005 250 mg BID	oral administration for 78 weeks
BG002	ELND005 1000 mg BID	oral administration for 78 weeks
BG003	ELND005 2000 mg BID	oral administration for 78 weeks
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00073.4± 7.83 BG00173.4± 7.26 BG00273.4± 7.56 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00047 BG00151 BG002

Region of Enrollment

Number

patients

Title

Denominators

Categories

United States

Title	Measurements
	BG00068 BG00175 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)

The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.

Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

Posted

Mean

Standard Error

Scores on a Scale

Baseline and 78 weeks

ID	Title	Description
OG000	Placebo BID	oral administration for 78 weeks
OG001	ELND005 250 mg BID	oral administration for 78 weeks
OG002	ELND005 1000 mg BID	oral administration for 78 weeks
OG003	ELND005 2000 mg BID	oral administration for 78 weeks

Units	Counts
Participants	OG00082 OG00184 OG0020 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.383± 0.075 OG001-0.350± 0.074

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		0.71		Mean Difference (Final Values)	0.03	Standard Error of the Mean	0.09	2-Sided	95	-0.14	0.21					Superiority or Other (legacy)

Secondary

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)

The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.

Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

Posted

Mean

Standard Error

Scores on a Scale

Baseline and 78 weeks

ID	Title	Description
OG000	Placebo BID	oral administration for 78 weeks
OG001	ELND005 250 mg BID	oral administration for 78 weeks
OG002	ELND005 1000 mg BID	oral administration for 78 weeks
OG003	ELND005 2000 mg BID	oral administration for 78 weeks

Primary

Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)

Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.

Posted

Mean

Standard Error

Scores on a Scale

Baseline and 78 weeks

ID	Title	Description
OG000	Placebo BID	oral administration for 78 weeks
OG001	ELND005 250 mg BID	oral administration for 78 weeks
OG002	ELND005 1000 mg BID	oral administration for 78 weeks
OG003

Primary

Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)

The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.

Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

Posted

Mean

Standard Error

Scores on a Scale

Baseline and 78 weeks

ID	Title	Description
OG000	Placebo BID	oral administration for 78 weeks
OG001	ELND005 250 mg BID	oral administration for 78 weeks
OG002	ELND005 1000 mg BID	oral administration for 78 weeks
OG003	ELND005 2000 mg BID	oral administration for 78 weeks

Primary

Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)

Posted

Mean

Standard Error

Scores on a Scale

Baseline and 78 weeks

ID	Title	Description
OG000	Placebo BID	oral administration for 78 weeks
OG001	ELND005 250 mg BID	oral administration for 78 weeks
OG002	ELND005 1000 mg BID	oral administration for 78 weeks
OG003	ELND005 2000 mg BID	oral administration for 78 weeks

Secondary

Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)

The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.

Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

Posted

Mean

Standard Error

Scores on a Scale

Baseline and 78 weeks

ID	Title	Description
OG000	Placebo BID	oral administration for 78 weeks
OG001	ELND005 250 mg BID	oral administration for 78 weeks
OG002	ELND005 1000 mg BID	oral administration for 78 weeks
OG003	ELND005 2000 mg BID	oral administration for 78 weeks

Secondary

Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)

The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.

Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

Posted

Mean

Standard Error

Scores on a Scale

Baseline and 78 weeks

ID	Title	Description
OG000	Placebo BID	oral administration for 78 weeks
OG001	ELND005 250 mg BID	oral administration for 78 weeks
OG002	ELND005 1000 mg BID	oral administration for 78 weeks
OG003	ELND005 2000 mg BID	oral administration for 78 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo BID	oral administration for 78 weeks	11	83	48	83
EG001	ELND005 250 mg BID	oral administration for 78 weeks	19	88	46	88
EG002	ELND005 1000 mg BID	oral administration for 78 weeks	20	89	45	89
EG003	ELND005 2000 mg BID	oral administration for 78 weeks	21	91	57	91

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Unstable	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG0030 affected91 at risk
Atrial Fribrillation	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0011 affected88 at risk EG0021 affected89 at risk EG003
Atrial Futter	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Cardiac Arrest	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Cardiac Failure Congestive	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Coronary Artery Occlusion	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Myocardial Infarction	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Supraventricular Tachycardia	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Glaucoma	Eye disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Retinal Vein Occlusion	Eye disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Vitreous Haemorrhage	Eye disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Gastritis	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Gastritis Hemorrhagic	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Hemorrhoidal hemorrhage	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Pancreatitis	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Hypothermia	General disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Sudden Death	General disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Cholecystitis	Hepatobiliary disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Arthritis Bacterial	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Bacterial Sepsis	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Kidney Infection	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Pneumonia	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0022 affected89 at risk EG003
Pneumonia Bacterial	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Staphylococcal Infection	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Urinary Tract Infection	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Urosepsis	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Viral Infection	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Accidental Overdose	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Compression Fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Contusion	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Fall	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Hip Fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Jaw Fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Laceration	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Multiple Fractures	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Post Procedural Haematoma	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Postoperative Ileus	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Subdural Hematoma	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Electrocardiogram Change	Investigations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Hepatic Enzyme Increased	Investigations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Lipase Increased	Investigations	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Dehydration	Metabolism and nutrition disorders	CTCAE (3.0)	Systematic Assessment	EG0002 affected83 at risk EG0011 affected88 at risk EG0022 affected89 at risk EG003
Failure to Thrive	Metabolism and nutrition disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Mobility Decreased	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0013 affected88 at risk EG0020 affected89 at risk EG003
Breast Cancer In Situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Colorectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Carotid Artery Occlusion	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Cerebral Hemorrhage	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Cerebrovascular Accident	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Dementia Alzheimer's Type	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Dizziness	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Encephalopathy	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Haemorrhagic Stroke	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Ischaemic Cerebral Infarction	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Syncope	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Transient Ischaemic Attack	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Acute Psychosis	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Agitation	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0021 affected89 at risk EG003
Confusional State	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Delirium	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Mental Status Changes	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected88 at risk EG0020 affected89 at risk EG003
Psychotic Disorder	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Renal Failure Acute	Renal and urinary disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0022 affected89 at risk EG003
Urinary Retention	Renal and urinary disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0022 affected89 at risk EG003
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0022 affected89 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003
Aortic Thrombosis	Vascular disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Deep Vein Thrombosis	Vascular disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected88 at risk EG0020 affected89 at risk EG003
Haemorrhagic Anaemia	Blood and lymphatic system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected88 at risk EG0021 affected89 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0006 affected83 at risk EG0019 affected88 at risk EG0028 affected89 at risk EG00312 affected91 at risk
Nausea	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0004 affected83 at risk EG0018 affected88 at risk EG0023 affected89 at risk EG003
Vomiting	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0003 affected83 at risk EG0015 affected88 at risk EG0023 affected89 at risk EG003
Fatigue	General disorders	CTCAE (3.0)	Systematic Assessment	EG0004 affected83 at risk EG0016 affected88 at risk EG0026 affected89 at risk EG003
Urinary Tract Infection	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0007 affected83 at risk EG00112 affected88 at risk EG0024 affected89 at risk EG003
Fall	Injury, poisoning and procedural complications	CTCAE (3.0)	Systematic Assessment	EG0005 affected83 at risk EG00111 affected88 at risk EG00210 affected89 at risk EG003
Dizziness	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0007 affected83 at risk EG0014 affected88 at risk EG0026 affected89 at risk EG003
Headache	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG00012 affected83 at risk EG0014 affected88 at risk EG00211 affected89 at risk EG003
Agitation	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0005 affected83 at risk EG0014 affected88 at risk EG0029 affected89 at risk EG003
Confusional State	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0003 affected83 at risk EG0017 affected88 at risk EG0024 affected89 at risk EG003
Depression	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0004 affected83 at risk EG00110 affected88 at risk EG0024 affected89 at risk EG003
Insomnia	Psychiatric disorders	CTCAE (3.0)	Systematic Assessment	EG0005 affected83 at risk EG0013 affected88 at risk EG0022 affected89 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0005 affected83 at risk EG0019 affected88 at risk EG0023 affected89 at risk EG003

The two high dose groups of ELND005 were discontinued before study end, so the efficacy analysis was based only on placebo and ELND005 250 mg bid groups.

Certain Agreements

Point of Contact

Title	Organization	Phone	Extension	Email
Aleksandra pastrak, MD, PhD, Vice President, Clinical Development	Transition Therapeutics Ireland Limited	+1 416 263 1227		apastrak@transitiontherapeutics.com

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
C009217	scyllitol

Units	Counts
Participants	OG00082 OG00184 OG0020 OG0030

Units	Counts
Participants	OG00082 OG00184 OG0020 OG0030

Units	Counts
Participants	OG00082 OG00184 OG0020 OG0030