Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)

• Sponsor: Avid Radiopharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00857506
• Collaborator: (none)
• Enrollment: 152
• Locations: 8
• Duration (Months): 35
• Patients Per Site: 19
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease.

Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative.

The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.

Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease; Mild Cognitive Impairment	Drug: florbetapir F 18	Phase 2

Detailed Description

Study AV-45-A11 is designed to determine if brain amyloid aggregation imaged on 18F-AV-45 PET scans is predictive of progression of cognitive impairment during the subsequent 36 months. Approximately 180 subjects enrolled in a prior clinical study (AV-45-A05[NCT00702143]) will be offered an opportunity to be studied under this protocol. The initial visit will occur as soon as possible following the AV-45-A05(NCT00702143) imaging day. Subjects who qualify for the study and their caregiver/partners will be contacted approximately 6,12,18,24 and 36 months after PET imaging in study AV-45-A05(NCT00702143), and will undergo a standardized functional and psychometric evaluation.

NOTE: This study is a clinical follow-up of subjects previously enrolled in trial 18F-AV-45-A05(NCT00702143). No new patients are being enrolled in this trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Longitudinal Study of Long-term (36 Month) Cognitive Outcomes in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD) Who Have Previously Had PET Imaging With 18F-AV-45 Injection.
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Outcome Measures

Primary Outcome Measures

1. Change in ADAS-Cog for MCI Subjects [Baseline and 36 months]

   The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (last observation carried forward [LOCF]). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.

Secondary Outcome Measures

1. Cognitive Decline in MCI Subjects [Baseline and 36 months]

   The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the MCI population with clinically significant deterioration in ADAS-Cog (≥4) and Clinical Dementia Rating (CDR) global score (≥0.5) and conversion in diagnosis from MCI at baseline to AD or Cognitively Normal (CN) at 36 months. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).

2. Change in ADAS-Cog in CN and AD Subjects [Baseline and 36 months]

   This analysis compared the magnitude of change from baseline in ADAS cognitive subscale (ADAS-Cog) scores between Aβ+ and Aβ- subjects in the CN and AD populations at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.

3. Cognitive Decline in CN and AD Subjects [Baseline and 36 months]

   The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the CN and AD populations with clinically significant deterioration in ADAS-Cog (≥4) and CDR global score (≥0.5). ADAS-Cog scores (range 0-70) indicate performance on a series of cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).

4. Covariate Adjusted Psychometric Score Change [Baseline and 36 months]

   Change from baseline by diagnostic group in covariate-adjusted psychometric assessment scores at month 36 (LOCF). Assessments included Digit Symbol Substitution (DSS), Clinical Dementia Rating Sum of Boxes (CDR-SOB), Mini-Mental State Examination (MMSE), Wechsler Logical Memory Scale (WLMS) delayed and immediate recall, Category Verbal Fluency (CVF) animals and vegetables, Alzheimer's Disease Clinical Studies Consortium Activities of Daily Living (ADCS ADL) and Geriatric Depression Scale (GDS). The ranges for these scales are as follows: DSS (0-93), CDR-SOB (0-18), MMSE (0-30), WLMS delayed and immediate recall (0-25), CVF animals and vegetables (0-total number of relevant items named in 60 seconds), ADCS ADL (0-78) and GDS (0-15). For all scales except CDR-SOB and GDS a higher score indicates greater cognitive function. For CDR-SOB and GDS a higher score indicates increased dementia or depression, respectively.

5. Correlation of Change in ADAS-Cog and SUVR [Baseline and 36 months]

   Correlation between change from baseline to 36 month ADAS-Cog score and baseline global average SUVR by diagnostic group is provided below. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. Standard Uptake Value Ratio (SUVR) is the ratio of tracer uptake in the cortex and cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the cortex as compared to the cerebellum whereas scores less than 1 indicate the opposite.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All subjects who enrolled in study AV-45-A05(NCT00702143), received 18F-AV-45, and completed a PET scan will be eligible to enroll in this trial.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Scottsdale	Arizona	United States	85258
2	Research Site	Tucson	Arizona	United States	85741
3	Research Site	Costa Mesa	California	United States	92626
4	Research Site	Brooksville	Florida	United States	34613
5	Research Site	Hallandale Beach	Florida	United States	33009
6	Research Site	West Palm Beach	Florida	United States	33407
7	Research Site	Albany	New York	United States	12208
8	Research Site	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Avid Radiopharmaceuticals

Investigators

• Study Director: Chief Medical Officer, Avid Radiopharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avid Radiopharmaceuticals
• ClinicalTrials.gov Identifier: NCT00857506
• Other Study ID Numbers: 18F-AV-45-A11
• First Posted: Mar 6, 2009
• Last Update Posted: Mar 28, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Avid Radiopharmaceuticals: Cognitive outcome; 18F-AV-45 PET scan; Amyloid PET scan; Florbetapir F 18 amyloid PET scan; Normal cognition; Change in cognitive status in relation to brain amyloid on PET
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

Participant Flow

Recruitment Details	All subjects were recruited from participants in study 18F-AV-45-A05 (NCT00702143)

Arm/Group Title	Alzheimer's Disease	Mild Cognitive Impairment	Cognitively Normal
Arm/Group Description	Subject's with Alzheimer's Disease were recruited from study 18F-AV-45-A05 (NCT00702143). None of these subjects received additional interventions in study 18F-AV-45-A11.	Subject's with Mild Cognitive Impairment (MCI) were recruited from study 18F-AV-45-A05 (NCT00702143). 36 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.	Cognitively Normal (CN) subjects were recruited from study 18F-AV-45-A05 (NCT00702143). 50 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
Period Title: Overall Study
STARTED	31	52	69
COMPLETED	16	37	51
NOT COMPLETED	15	15	18

Baseline Characteristics

Arm/Group Title	Alzheimer's Disease	Mild Cognitive Impairment	Cognitively Normal	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	31	52	69	152
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.7 (9.23)	71.5 (10.09)	69.8 (11.26)	71.8 (10.73)
Sex: Female, Male (Count of Participants)
Female	13 41.9%	29 55.8%	41 59.4%	83 54.6%
Male	18 58.1%	23 44.2%	28 40.6%	69 45.4%
Region of Enrollment (participants) [Number]
United States	31 100%	52 100%	69 100%	152 100%

Outcome Measures

1. Primary Outcome

Title	Change in ADAS-Cog for MCI Subjects
Description	The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (last observation carried forward [LOCF]). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.
Time Frame	Baseline and 36 months

Outcome Measure Data

Analysis Population Description

Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).

Arm/Group Title	Amyloid-Beta Positive MCI Subjects	Amyloid-Beta Negative MCI Subjects
Arm/Group Description	MCI subjects with a positive florbetapir F 18 PET scan at baseline.	MCI subjects with a negative florbetapir F 18 PET scan at baseline.
Measure Participants	17	30
Mean (Standard Error) [Scores on a scale]	5.664 (1.4667)	-0.710 (1.0905)

2. Secondary Outcome

Title	Cognitive Decline in MCI Subjects
Description	The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the MCI population with clinically significant deterioration in ADAS-Cog (≥4) and Clinical Dementia Rating (CDR) global score (≥0.5) and conversion in diagnosis from MCI at baseline to AD or Cognitively Normal (CN) at 36 months. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).
Time Frame	Baseline and 36 months

Outcome Measure Data

Analysis Population Description

Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).

Arm/Group Title	Amyloid-Beta Positive MCI Subjects	Amyloid-Beta Negative MCI Subjects
Arm/Group Description	MCI subjects with a positive florbetapir F 18 PET scan at baseline.	MCI subjects with a negative florbetapir F 18 PET scan at baseline.
Measure Participants	17	30
ADAS-Cog Deterioration ≥4	8 25.8%	3 5.8%
CDR Deterioration ≥0.5	5 16.1%	4 7.7%
Conversion to AD	6 19.4%	3 5.8%
Conversion to CN	1 3.2%	5 9.6%

3. Secondary Outcome

Title	Change in ADAS-Cog in CN and AD Subjects
Description	This analysis compared the magnitude of change from baseline in ADAS cognitive subscale (ADAS-Cog) scores between Aβ+ and Aβ- subjects in the CN and AD populations at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.
Time Frame	Baseline and 36 months

Outcome Measure Data

Analysis Population Description

Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).

Arm/Group Title	Amyloid-Beta Positive CN Subjects	Amyloid-Beta Negative CN Subjects	Amyloid-Beta Positive AD Subjects	Amyloid-Beta Negative AD Subjects
Arm/Group Description	CN subjects with a positive florbetapir F 18 PET scan at baseline.	CN subjects with a negative florbetapir F 18 PET scan at baseline.	AD subjects with a positive florbetapir F 18 PET scan at baseline.	AD subjects with a negative florbetapir F 18 PET scan at baseline.
Measure Participants	10	57	19	9
Mean (Standard Error) [Scores on a scale]	3.237 (0.9043)	-0.094 (0.3679)	8.879 (2.8812)	3.811 (4.4261)

4. Secondary Outcome

Title	Cognitive Decline in CN and AD Subjects
Description	The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the CN and AD populations with clinically significant deterioration in ADAS-Cog (≥4) and CDR global score (≥0.5). ADAS-Cog scores (range 0-70) indicate performance on a series of cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).
Time Frame	Baseline and 36 months

Outcome Measure Data

Analysis Population Description

Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).

Arm/Group Title	Amyloid-Beta Positive CN Subjects	Amyloid-Beta Negative CN Subjects	Amyloid-Beta Positive AD Subjects	Amyloid-Beta Negative AD Subjects
Arm/Group Description	CN subjects with a positive florbetapir F 18 PET scan at baseline.	CN subjects with a negative florbetapir F 18 PET scan at baseline. 57 subjects were analyzed for change in ADAS-Cog and 55 subjects were analyzed for change in CDR.	AD subjects with a positive florbetapir F 18 PET scan at baseline.	AD subjects with a negative florbetapir F 18 PET scan at baseline.
Measure Participants	10	57	19	9
ADAS-Cog Deterioration ≥4	4 12.9%	3 5.8%	14 20.3%	3 2%
CDR Deterioration ≥0.5	4 12.9%	5 9.6%	12 17.4%	2 1.3%

5. Secondary Outcome

Title	Covariate Adjusted Psychometric Score Change
Description	Change from baseline by diagnostic group in covariate-adjusted psychometric assessment scores at month 36 (LOCF). Assessments included Digit Symbol Substitution (DSS), Clinical Dementia Rating Sum of Boxes (CDR-SOB), Mini-Mental State Examination (MMSE), Wechsler Logical Memory Scale (WLMS) delayed and immediate recall, Category Verbal Fluency (CVF) animals and vegetables, Alzheimer's Disease Clinical Studies Consortium Activities of Daily Living (ADCS ADL) and Geriatric Depression Scale (GDS). The ranges for these scales are as follows: DSS (0-93), CDR-SOB (0-18), MMSE (0-30), WLMS delayed and immediate recall (0-25), CVF animals and vegetables (0-total number of relevant items named in 60 seconds), ADCS ADL (0-78) and GDS (0-15). For all scales except CDR-SOB and GDS a higher score indicates greater cognitive function. For CDR-SOB and GDS a higher score indicates increased dementia or depression, respectively.
Time Frame	Baseline and 36 months

Outcome Measure Data

Analysis Population Description

Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).

Arm/Group Title	Amyloid-Beta Positive CN Subjects	Amyloid-Beta Negative CN Subjects	Amyloid-Beta Positive MCI Subjects	Amyloid-Beta Negative MCI Subjects	Amyloid-Beta Positive AD Subjects	Amyloid-Beta Negative AD Subjects
Arm/Group Description	CN subjects with a positive florbetapir F 18 PET scan at baseline.	CN subjects with a negative florbetapir F 18 PET scan at baseline. All assessments were obtained for 57 subjects except for CDR-SOB and ADCS ADL which were obtained for 55 and 56 subjects respectively.	MCI subjects with a positive florbetapir F 18 PET scan at baseline.	MCI subjects with a negative florbetapir F 18 PET scan at baseline.	AD subjects with a positive florbetapir F 18 PET scan at baseline.	AD subjects with a negative florbetapir F 18 PET scan at baseline.
Measure Participants	10	57	17	30	19	9
DSS	-6.521 (2.9117)	0.214 (1.1709)	-10.940 (2.1569)	0.133 (1.6082)	-5.995 (2.2381)	-0.011 (3.3534)
CDR-SOB	0.765 (0.1520)	0.097 (0.0632)	1.985 (0.5321)	0.392 (0.3976)	4.048 (0.8008)	0.121 (1.1739)
MMSE	-0.740 (0.3282)	-0.396 (0.1329)	-2.882 (0.8053)	-0.300 (0.6023)	-3.924 (1.2418)	1.173 (1.8299)
WLMS delayed recall	-0.429 (1.1278)	0.970 (0.4504)	-1.459 (1.1250)	0.493 (0.8386)	-0.179 (0.6722)	1.490 (1.10058)
WLMS immediate recall	-0.926 (1.0560)	0.934 (0.4211)	-1.875 (0.9949)	0.496 (0.7405)	-0.891 (0.8151)	-0.231 (1.2620)
CVF animals	-2.785 (1.5735)	-0.617 (0.6383)	-3.177 (1.0980)	-0.533 (0.8213)	-4.772 (0.8096)	0.085 (1.2654)
CVF vegetables	-2.087 (1.0202)	0.156 (0.4150)	-2.278 (0.8162)	0.757 (0.6109)	-3.051 (0.7022)	0.621 (1.0959)
ADCS ADL	-0.629 (0.7272)	-0.191 (0.2796)	-4.932 (2.2040)	-2.839 (1.6288)	-20.789 (4.5189)	-5.668 (6.6271)
GDS	-0.164 (0.4780)	-0.182 (0.1926)	0.066 (0.4753)	-0.171 (0.3546)	0.530 (0.5679)	-0.727 (0.8264)

6. Secondary Outcome

Title	Correlation of Change in ADAS-Cog and SUVR
Description	Correlation between change from baseline to 36 month ADAS-Cog score and baseline global average SUVR by diagnostic group is provided below. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. Standard Uptake Value Ratio (SUVR) is the ratio of tracer uptake in the cortex and cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the cortex as compared to the cerebellum whereas scores less than 1 indicate the opposite.
Time Frame	Baseline and 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alzheimer's Disease	Mild Cognitive Impairment	Cognitively Normal
Arm/Group Description	Subjects with a baseline clinical diagnosis of AD.	Subjects with a baseline clinical diagnosis of MCI.	Subjects with a baseline clinical diagnosis of CN.
Measure Participants	28	47	67
Number [Pearson Correlation Coefficient]	0.364	0.502	0.308

Adverse Events

Adverse Event Reporting Description	The number of subjects at risk was determined by the number of subjects who received an injection of florbetapir F 18 at the 24 month time point of study 18F-AV-45-A11. As indicated in the participant flow group description, there were 36 MCI and 50 CN subjects who qualified for inclusion in the safety set.
Arm/Group Title	Alzheimer's Disease		Mild Cognitive Impairment		Cognitively Normal
Arm/Group Description
All Cause Mortality
	Alzheimer's Disease		Mild Cognitive Impairment		Cognitively Normal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Alzheimer's Disease		Mild Cognitive Impairment		Cognitively Normal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/36 (2.8%)		0/50 (0%)
Respiratory, thoracic and mediastinal disorders
Influenza	0/0 (NaN)	0	1/36 (2.8%)	1	0/50 (0%)	0
Other (Not Including Serious) Adverse Events
	Alzheimer's Disease		Mild Cognitive Impairment		Cognitively Normal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/36 (2.8%)		1/50 (2%)
Gastrointestinal disorders
Nausea	0/0 (NaN)	0	1/36 (2.8%)	1	0/50 (0%)	0
Nervous system disorders
Headache	0/0 (NaN)	0	0/36 (0%)	0	1/50 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.