Analysis of 18F-AV-1451 PET Imaging in Cognitively Health... | NCT02016560

Description Module

Detailed Description

This study was conducted in 2 phases: a Phase 2 Exploratory Phase and a Phase 3 Confirmatory Phase. An overarching goal of the Exploratory Phase of this protocol was to further investigate the pattern of flortaucipir PET imaging across the disease course, in cognitively healthy subjects through patients with cognitive decline. To accomplish this goal, the protocol investigated flortaucipir results in younger and older cognitively healthy normal volunteers and patients with clinical diagnoses for cognitive complaints, ranging from MCI to mild and moderate AD dementia. Additionally, the Exploratory Phase of this protocol investigated relationships between flortaucipir PET signal and cognitive decline over the 18-month study period.

The second, Confirmatory Phase of the study was designed to provide independent validation of the relationships observed in the exploratory analyses of the first phase. In particular, the goal of the second phase was to confirm the relationship between flortaucipir uptake in the brain as measured by PET signals at baseline and the subsequent rate of cognitive decline observed over the 18-month longitudinal follow up.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exploratory Cognitively Healthy Subjects	Experimental	Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline.	Drug: florbetapir F 18 Drug: Flortaucipir F18 Procedure: Brain PET Scan
Exploratory MCI Subjects	Experimental	Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.	Drug: florbetapir F 18 Drug: Flortaucipir F18 Procedure: Brain PET Scan
Exploratory AD Subjects	Experimental	Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.	Drug: florbetapir F 18 Drug: Flortaucipir F18 Procedure: Brain PET Scan
Confirmatory Subjects	Experimental	Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and flortaucipir at baseline.	Drug: florbetapir F 18 Drug: Flortaucipir F18

Name	Type	Description	Arm Group Labels	Other Names
florbetapir F 18	Drug		Confirmatory Subjects Exploratory AD Subjects Exploratory Cognitively Healthy Subjects Exploratory MCI Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline	Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.	between baseline and 18 months
Exploratory Phase: Cross-sectional Flortaucipir Imaging Results	Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.	baseline scan
Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status	Assess the rate of change of tau deposition as measured by flortaucipir uptake (SUVr) over time. Change = 18 months SUVr - baseline SUVr.	baseline and 18 months

Secondary Outcomes

Measure	Description	Time Frame
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read	This analysis used dichotomized CDR-SB change as a truth standard (1 point or more worsening = true positive vs. less than 1 point worsening = true negative) to assess the diagnostic performance of baseline Advanced AD tau status (τAD++) as determined by flortaucipir scan interpretation. Sensitivity and Specificity were calculated for each of the 5 independent imaging readers. Sensitivity is the percentage of true positive cases correctly identified by an Advanced AD pattern scan. Specificity is the percentage of true negative cases correctly identified by scans that were not classified as Advanced AD pattern.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Banner Alzheimer's Institute		Phoenix	Arizona	85006	United States
Four Peaks Neurology

PubMed Identifier	Type	Citation	Retractions
33587110	Derived	Lu M, Pontecorvo MJ, Devous MD Sr, Arora AK, Galante N, McGeehan A, Devadanam C, Salloway SP, Doraiswamy PM, Curtis C, Truocchio SP, Flitter M, Locascio T, Devine M, Zimmer JA, Fleisher AS, Mintun MA; AVID Collaborators. Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. JAMA Neurol. 2021 Apr 1;78(4):445-453. doi: 10.1001/jamaneurol.2020.5505.

ID	Title	Description
FG000	Exploratory Young Cognitively Healthy Subjects	Male or female subjects ≥20 to ≤40 years of age with mini-mental status exam (MMSE) score ≥29
FG001	Exploratory Older Cognitively Healthy Subjects

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 7, 2015	Jun 27, 2020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age, Continuous for Exploratory Cohort only

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00016 ParticipantsBG00158 ParticipantsBG00298 ParticipantsBG003

Age, Continuous

Age, Continuous for Confirmatory Cohort only

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Sex: Female, Male

Exploratory Cohort - Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00016 ParticipantsBG00158 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00016 ParticipantsBG00158 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
Asian	ParticipantsBG00016 ParticipantsBG00158 ParticipantsBG002

Clinical Dementia Rating - Sum of Boxes (CDR-SB)

The CDR scale (Berg 1988) examines 6 cognitive functioning domains individually on a scale of 0 to 3. CDR Sum of Boxes is generated by summing the total score across domains. Scores range from 0 to 18, with higher scores indicating higher levels of cognitive impairment.

Recorded at baseline only for confirmatory phase subjects

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010

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

Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline

Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.

Subjects from the confirmatory phase with valid flortaucipir visual read and 9 or 18 month clinical follow-up.

Posted

Count of Participants

Participants

between baseline and 18 months

ID	Title	Description
OG000	Predicted to Progress	Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).
OG001	Not Predicted to Progress	Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.

Units	Counts
Participants	OG00063 OG00168

Title

Denominators

Categories

Title	Measurements
Clinically meaningful progression	OG00036 OG00131
Did Not Progress	OG000

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	The specific hypothesis tested was that the hazard of progressing to the clinically meaningful event (defined as CDR-SB value change of at least 1 within 18 months) will be significantly greater for subjects with flortaucipir scans rated by majority interpretation as predicted to progress (Advanced AD scan pattern), as compared to subjects with scans rated as not predicted to progress (Moderate or Not AD scan pattern).	Cox proportional hazards	The Cox proportional hazard model was adjusted for baseline age, American National Adult Reading Test (ANART) score, and baseline CDR-SB score.	0.067	A p-value of <0.05 was the a priori threshold for statistical significance.	Cox Proportional Hazard	1.581			2-Sided	95	0.968	2.581

Primary

Exploratory Phase: Cross-sectional Flortaucipir Imaging Results

Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Analysis included all subjects who received an injection of flortaucipir, had valid quantifiable flortaucipir imaging data available, and valid quantifiable florbetapir PET data.

Posted

Least Squares Mean

Standard Error

standardized uptake value ratio (SUVr)

baseline scan

ID	Title	Description
OG000	Exploratory AD Subjects	Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE >10
OG001	Exploratory MCI Subjects	Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24
OG002	Exploratory Older Cognitively Healthy Subjects	Male or female subjects ≥50 years of age with MMSE ≥29
OG003

Primary

Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status

Assess the rate of change of tau deposition as measured by flortaucipir uptake (SUVr) over time. Change = 18 months SUVr - baseline SUVr.

Analysis of flortaucipir SUVr Change Over Time by Amyloid Status, Exploratory Phase Efficacy Population (AD and MCI subjects only)

Posted

Least Squares Mean

Standard Error

standardized uptake value ratio (SUVr)

baseline and 18 months

ID	Title	Description
OG000	Exploratory AB+ (Amyloid Beta Positive)	Exploratory MCI or AD subjects with a positive florbetapir PET scan for amyloid
OG001	Exploratory AB- (Amyloid Beta Negative)	Exploratory MCI or AD subjects with a negative florbetapir PET scan for amyloid

Units	Counts
Participants	OG000

Secondary

Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read

This analysis used dichotomized CDR-SB change as a truth standard (1 point or more worsening = true positive vs. less than 1 point worsening = true negative) to assess the diagnostic performance of baseline Advanced AD tau status (τAD++) as determined by flortaucipir scan interpretation. Sensitivity and Specificity were calculated for each of the 5 independent imaging readers. Sensitivity is the percentage of true positive cases correctly identified by an Advanced AD pattern scan. Specificity is the percentage of true negative cases correctly identified by scans that were not classified as Advanced AD pattern.

All confirmatory phase subjects who completed 18 months of follow-up for the cognitive endpoint were read by each reader

Posted

Number

95% Confidence Interval

percentage of cases correctly identified

baseline and 18 months

ID	Title	Description
OG000	Independent Readers	Scans were interpreted by 5 imaging physicians, blind to clinical data, after training by an Avid expert.

Units	Counts
Participants	OG000

Secondary

Exploratory Phase: Correlation Between Flortaucipir SUVr and Age

Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Exploratory Young and Old healthy control subjects with a valid flortaucipir PET scan

Posted

Mean

Standard Deviation

standardized uptake value ratio (SUVr)

baseline scan

ID	Title	Description
OG000	Exploratory Young Cognitively Healthy Subjects	Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29
OG001	Exploratory Older Cognitively Healthy Subjects 50-59	Male or female subjects 50-59 years of age with MMSE ≥29
OG002	Exploratory Older Cognitively Healthy Subjects 60-69	Male or female subjects 60-69 years of age with MMSE ≥29
OG003	Exploratory Older Cognitively Healthy Subjects 70-79	Male or female subjects 70-79 years of age with MMSE ≥29

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Exploratory Younger Cognitively Healthy Subjects	Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	16	0	16	3	16
EG001	Exploratory Older Cognitively Healthy Subjects	Male or female subjects ≥50 years of age with MMSE ≥29	58	0	58	17	58
EG002	Exploratory MCI Subjects	Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24	98	1	98	21	98
EG003	Exploratory AD Subjects	Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE >10	51	0	51	13	51
EG004	Confirmatory Subjects MCI	Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	98	0	98	13	98
EG005	Confirmatory Subjects AD	Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	62	0	62	0	62

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0022 affected98 at risk EG0030 affected51 at risk EG0040 affected98 at risk EG0050 affected62 at risk
Bradycardia	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Injection site pain	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0015 affected58 at risk EG0028 affected98 at risk EG003
Injection site extravasation	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0023 affected98 at risk EG003
Fatigue	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0012 affected58 at risk EG0021 affected98 at risk EG003
Application site irritation	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Application site laceration	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Feeling abnormal	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Therapeutic response unexpected	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Blood pressure increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0012 affected58 at risk EG0022 affected98 at risk EG003
Blood pressure systolic increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0012 affected58 at risk EG0020 affected98 at risk EG003
Platelet count decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Heart rate increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Headache	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0013 affected58 at risk EG0023 affected98 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Amnesia	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Dizziness	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Head discomfort	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Memory impairment	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Somnolence	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0011 affected58 at risk EG0020 affected98 at risk EG003
Hot flush	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0021 affected98 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Cyanopsia	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Eye irritation	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Panic attack	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 affected16 at risk EG0010 affected58 at risk EG0020 affected98 at risk EG003

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	Title	Description
BG000	Exploratory Young Cognitively Healthy Subjects	Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29
BG001	Exploratory Older Cognitively Healthy Subjects	Male or female subjects ≥50 years of age with MMSE ≥29
BG002	Exploratory MCI Subjects	Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24
BG003	Exploratory AD Subjects	Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE >10
BG004	Confirmatory Subjects MCI	Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
BG005	Confirmatory Subjects AD	Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
BG006	Total	Total of all reporting groups

ID	Term
C545186	florbetapir
C000591008	7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole