ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE)

This study has been completed.

Sponsor:

Collaborators:

National Institute on Aging (NIA)

National Institute of Nursing Research (NINR)

Information provided by (Responsible Party):

New England Research Institutes

ClinicalTrials.gov Identifier:

NCT00298558

First received: February 28, 2006

Last updated: March 24, 2014

Last verified: January 2014

History of Changes

Results First Received: April 24, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Prevention
Conditions:	Aging Healthy
Intervention:	Behavioral: Cognitive Training

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred from March 1998 through October 1999 at six metropolitan field centers: University of Alabama at Birmingham, Boston Hebrew Rehabilitation Center for Aged (now Hebrew Senior Life), Indiana University School of Medicine, Johns Hopkins University, Pennsylvania State University, and Wayne State University.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility and demographics were gathered at telephone screening.Health history, physical status, functional status, mental status, cognitive and function measures were gathered via in-person exams in individual and small-group formats at baseline.Eligible subjects were randomly assigned to one of three interventions or no-contact control group.

Reporting Groups

	Description
Memory Training	Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
Reasoning Training	Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
Speed of Processing Training	Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
Control	This group did not complete any cognitive training interventions

Participant Flow for 9 periods

Period 1: Baseline

	Memory Training	Reasoning Training	Speed of Processing Training	Control
STARTED	711	705	712	704
COMPLETED	711	705	712	704
NOT COMPLETED	0	0	0	0

Period 2: Intervention

	Memory Training	Reasoning Training	Speed of Processing Training	Control
STARTED	711	705	712	704
COMPLETED	620	627	637	285
NOT COMPLETED	91	78	75	419

Period 3: Immediate Post Test

	Memory Training	Reasoning Training	Speed of Processing Training	Control
STARTED	711	705	712	704
COMPLETED	640	629	653	639
NOT COMPLETED	71	76	59	65

Period 4: Booster

	Memory Training	Reasoning Training	Speed of Processing Training
STARTED	372	371	370
COMPLETED	283	301	295
NOT COMPLETED	89	70	75

Period 5: 1st Annual (A1)

	Memory Training	Reasoning Training	Speed of Processing Training	Control
STARTED	640	629	653	639
COMPLETED	585	566	601	584
NOT COMPLETED	55	63	52	55

Period 6: 2nd Annual (A2)

	Memory Training	Reasoning Training	Speed of Processing Training	Control
STARTED	585	566	601	584
COMPLETED	563	555	574	552
NOT COMPLETED	22	11	27	32

Period 7: 3rd Annual Booster

	Memory Training	Reasoning Training	Speed of Processing Training
STARTED	372	371	370
COMPLETED	250	243	230
NOT COMPLETED	122	128	140

Period 8: 3rd Annual (A3) and 5th Annual (A5)

	Memory Training	Reasoning Training	Speed of Processing Training	Control
STARTED	563	555	574	552
COMPLETED	472	469	490	448
NOT COMPLETED	91	86	84	104

Period 9: 10th Annual (A10)

	Memory Training	Reasoning Training	Speed of Processing Training	Control
STARTED	472	469	490	448
COMPLETED	300	316	319	285
NOT COMPLETED	172	153	171	163

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of 2832 randomized subjects, 30 subjects were randomized inappropriately in violation of the protocol and excluded from the analysis. Therefore, 2802 subjects were used for the baseline analysis.

Reporting Groups

	Description
Memory Training	Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
Reasoning Training	Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
Speed of Processing Training	Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
Control	This group did not complete any cognitive training interventions
Total	Total of all reporting groups

Baseline Measures

	Memory Training	Reasoning Training	Speed of Processing Training	Control	Total
Number of Participants [units: participants]	703	699	702	698	2802
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	0	0	0	0	0
>=65 years	703	699	702	698	2802
Age [units: years] Mean (Standard Deviation)	73.5 (6.02)	73.5 (5.76)	73.4 (5.78)	74.0 (6.05)	73.6 (5.91)
Gender [units: participants]
Female	537	537	538	514	2126
Male	166	162	164	184	676
Region of Enrollment [units: participants]
United States	703	699	702	698	2802

Outcome Measures

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1. Primary:

Changes in Cognitive Abilities of Memory From Baseline to Year 10 [ Time Frame: Up to 10 years ]

Show Outcome Measure 1

2. Primary:

Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 [ Time Frame: Up to 10 years ]

Show Outcome Measure 2

3. Primary:

Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ]

Show Outcome Measure 3

4. Primary:

Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 [ Time Frame: Up to 10 years ]

Show Outcome Measure 4

5. Primary:

Changes in Everyday Problem Solving From Baseline to Year 10 [ Time Frame: Up to 10 years ]

Show Outcome Measure 5

6. Primary:

Changes in Everyday Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ]

Show Outcome Measure 6

7. Secondary:

Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use [ Time Frame: 10th Year ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

8. Secondary:

Examine Health, Genetic and Cognitive Moderators [ Time Frame: 10th Year ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

9. Secondary:

Estimate the Effects of ACTIVE Training to General Population [ Time Frame: 10th Year ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 of 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact:

Name/Title: Sharon L. Tennstedt, PhD
Organization: New England Research Institutes
phone: 617-972-3362
e-mail: stennstedt@neriscience.com

Publications of Results:

Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81.

Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14.

Other Publications:

Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, Rebok GW, Morris JN, Helmers KF, Leveck MD, Kleinman K. ACTIVE: a cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001 Aug;22(4):453-79.

Jones RN, Rosenberg AL, Morris JN, Allaire JC, McCoy KJ, Marsiske M, Kleinman KP, Rebok GW, Malloy PF. A growth curve model of learning acquisition among cognitively normal older adults. Exp Aging Res. 2005 Jul-Sep;31(3):291-312.

Kuo HK, Jones RN, Milberg WP, Tennstedt S, Talbot L, Morris JN, Lipsitz LA. Cognitive function in normal-weight, overweight, and obese older adults: an analysis of the Advanced Cognitive Training for Independent and Vital Elderly cohort. J Am Geriatr Soc. 2006 Jan;54(1):97-103.

Diehl M, Marsiske M, Horgas AL, Rosenberg A, Saczynski JS, Willis SL. The Revised Observed Tasks of Daily Living: A Performance-Based Assessment of Everyday Problem Solving in Older Adults. J Appl Gerontol. 2005;24(3):211-230.

Wadley VG, Crowe M, Marsiske M, Cook SE, Unverzagt FW, Rosenberg AL, Rexroth D. Changes in everyday function in individuals with psychometrically defined mild cognitive impairment in the Advanced Cognitive Training for Independent and Vital Elderly Study. J Am Geriatr Soc. 2007 Aug;55(8):1192-8.

Cook SE, Marsiske M, Thomas KR, Unverzagt FW, Wadley VG, Langbaum JB, Crowe M. Identification of mild cognitive impairment in ACTIVE: algorithmic classification and stability. J Int Neuropsychol Soc. 2013 Jan;19(1):73-87. doi: 10.1017/S1355617712000938. Epub 2012 Oct 25.

Owsley C, Sloane M, McGwin G Jr, Ball K. Timed instrumental activities of daily living tasks: relationship to cognitive function and everyday performance assessments in older adults. Gerontology. 2002 Jul-Aug;48(4):254-65.

Gallo JJ, Rebok GW, Tennsted S, Wadley VG, Horgas A; Advanced Cognitive Training for Independent and Vital Elderly (Active) Study Investigators. Linking depressive symptoms and functional disability in late life. Aging Ment Health. 2003 Nov;7(6):469-80.

Caskie GI, Willis SL. Congruence of self-reported medications with pharmacy prescription records in low-income older adults. Gerontologist. 2004 Apr;44(2):176-85.

Edwards JD, Ross LA, Wadley VG, Clay OJ, Crowe M, Roenker DL, Ball KK. The useful field of view test: normative data for older adults. Arch Clin Neuropsychol. 2006 May;21(4):275-86. Epub 2006 May 15.

Wolinsky FD, Unverzagt FW, Smith DM, Jones R, Wright E, Tennstedt SL. The effects of the ACTIVE cognitive training trial on clinically relevant declines in health-related quality of life. J Gerontol B Psychol Sci Soc Sci. 2006 Sep;61(5):S281-7.

Crowe M, Andel R, Wadley V, Cook S, Unverzagt F, Marsiske M, Ball K. Subjective cognitive function and decline among older adults with psychometrically defined amnestic MCI. Int J Geriatr Psychiatry. 2006 Dec;21(12):1187-92.

Kuo HK, Jones RN, Milberg WP, Tennstedt S, Talbot L, Morris JN, Lipsitz LA. Effect of blood pressure and diabetes mellitus on cognitive and physical functions in older adults: a longitudinal analysis of the advanced cognitive training for independent and vital elderly cohort. J Am Geriatr Soc. 2005 Jul;53(7):1154-61.

Wolinsky FD, Unverzagt FW, Smith DM, Jones R, Stoddard A, Tennstedt SL. The ACTIVE cognitive training trial and health-related quality of life: protection that lasts for 5 years. J Gerontol A Biol Sci Med Sci. 2006 Dec;61(12):1324-9.

Ball K, Edwards JD, Ross LA. The impact of speed of processing training on cognitive and everyday functions. J Gerontol B Psychol Sci Soc Sci. 2007 Jun;62 Spec No 1:19-31. Review.

Rebok GW, Carlson MC, Langbaum JB. Training and maintaining memory abilities in healthy older adults: traditional and novel approaches. J Gerontol B Psychol Sci Soc Sci. 2007 Jun;62 Spec No 1:53-61. Review.

Unverzagt FW, Kasten L, Johnson KE, Rebok GW, Marsiske M, Koepke KM, Elias JW, Morris JN, Willis SL, Ball K, Rexroth DF, Smith DM, Wolinsky FD, Tennstedt SL. Effect of memory impairment on training outcomes in ACTIVE. J Int Neuropsychol Soc. 2007 Nov;13(6):953-60.

Edwards JD, Ross LA, Ackerman ML, Small BJ, Ball KK, Bradley S, Dodson JE. Longitudinal predictors of driving cessation among older adults from the ACTIVE clinical trial. J Gerontol B Psychol Sci Soc Sci. 2008 Jan;63(1):P6-12.

Morgan AA, Marsiske M, Whitfield KE. Characterizing and explaining differences in cognitive test performance between african american and European American older adults. Exp Aging Res. 2008 Jan-Mar;34(1):80-100. doi: 10.1080/03610730701776427.

Vance DE, Ross LA, Crowe MG, Wadley VG, Edwards JD, Ball KK. THE RELATIONSHIP OF MEMORY, REASONING, AND SPEED OF PROCESSING ON FALLING AMONG OLDER ADULTS. Phys Occup Ther Geriatr. 2008;27(3):212-228.

Ackerman ML, Edwards JD, Ross LA, Ball KK, Lunsman M. Examination of cognitive and instrumental functional performance as indicators for driving cessation risk across 3 years. Gerontologist. 2008 Dec;48(6):802-10.

Langbaum JB, Rebok GW, Bandeen-Roche K, Carlson MC. Predicting memory training response patterns: results from ACTIVE. J Gerontol B Psychol Sci Soc Sci. 2009 Jan;64(1):14-23. doi: 10.1093/geronb/gbn026. Epub 2009 Feb 4.

Tucker-Drob EM, Johnson KE, Jones RN. The cognitive reserve hypothesis: a longitudinal examination of age-associated declines in reasoning and processing speed. Dev Psychol. 2009 Mar;45(2):431-46. doi: 10.1037/a0014012.

Ross LA, Clay OJ, Edwards JD, Ball KK, Wadley VG, Vance DE, Cissell GM, Roenker DL, Joyce JJ. Do older drivers at-risk for crashes modify their driving over time? J Gerontol B Psychol Sci Soc Sci. 2009 Mar;64(2):163-70. doi: 10.1093/geronb/gbn034. Epub 2009 Feb 4.

Wolinsky FD, Vander Weg MW, Martin R, Unverzagt FW, Ball KK, Jones RN, Tennstedt SL. The effect of speed-of-processing training on depressive symptoms in ACTIVE. J Gerontol A Biol Sci Med Sci. 2009 Apr;64(4):468-72. doi: 10.1093/gerona/gln044. Epub 2009 Jan 30.

Wolinsky FD, Mahncke HW, Kosinski M, Unverzagt FW, Smith DM, Jones RN, Stoddard A, Tennstedt SL. The ACTIVE cognitive training trial and predicted medical expenditures. BMC Health Serv Res. 2009 Jun 29;9:109. doi: 10.1186/1472-6963-9-109.

Unverzagt FW, Smith DM, Rebok GW, Marsiske M, Morris JN, Jones R, Willis SL, Ball K, King JW, Koepke KM, Stoddard A, Tennstedt SL. The Indiana Alzheimer Disease Center's Symposium on Mild Cognitive Impairment. Cognitive training in older adults: lessons from the ACTIVE Study. Curr Alzheimer Res. 2009 Aug;6(4):375-83.

Wolinsky FD, Mahncke HW, Weg MW, Martin R, Unverzagt FW, Ball KK, Jones RN, Tennstedt SL. The ACTIVE cognitive training interventions and the onset of and recovery from suspected clinical depression. J Gerontol B Psychol Sci Soc Sci. 2009 Sep;64(5):577-85. doi: 10.1093/geronb/gbp061. Epub 2009 Jul 17.

Edwards JD, Lunsman M, Perkins M, Rebok GW, Roth DL. Driving cessation and health trajectories in older adults. J Gerontol A Biol Sci Med Sci. 2009 Dec;64(12):1290-5. doi: 10.1093/gerona/glp114. Epub 2009 Aug 12.

Edwards JD, Delahunt PB, Mahncke HW. Cognitive speed of processing training delays driving cessation. J Gerontol A Biol Sci Med Sci. 2009 Dec;64(12):1262-7. doi: 10.1093/gerona/glp131. Epub 2009 Sep 2.

Kvale EA, Clay OJ, Ross-Meadows LA, McGee JS, Edwards JD, Unverzagt FW, Ritchie CS, Ball KK. Cognitive speed of processing and functional declines in older cancer survivors: an analysis of data from the ACTIVE trial. Eur J Cancer Care (Engl). 2010 Jan 1;19(1):110-7. doi: 10.1111/j.1365-2354.2008.01018.x. Epub 2009 Aug 26.

Wolinsky FD, Mahncke H, Vander Weg MW, Martin R, Unverzagt FW, Ball KK, Jones RN, Tennstedt SL. Speed of processing training protects self-rated health in older adults: enduring effects observed in the multi-site ACTIVE randomized controlled trial. Int Psychogeriatr. 2010 May;22(3):470-8. doi: 10.1017/S1041610209991281. Epub 2009 Dec 15.

O'Connor ML, Edwards JD, Wadley VG, Crowe M. Changes in mobility among older adults with psychometrically defined mild cognitive impairment. J Gerontol B Psychol Sci Soc Sci. 2010 May;65B(3):306-16. doi: 10.1093/geronb/gbq003. Epub 2010 Feb 10.

Yen YC, Rebok GW, Gallo JJ, Jones RN, Tennstedt SL. Depressive symptoms impair everyday problem-solving ability through cognitive abilities in late life. Am J Geriatr Psychiatry. 2011 Feb;19(2):142-50. doi: 10.1097/JGP.0b013e3181e89894.

Wolinsky FD, Vander Weg MW, Martin R, Unverzagt FW, Willis SL, Marsiske M, Rebok GW, Morris JN, Ball KK, Tennstedt SL. Does cognitive training improve internal locus of control among older adults? J Gerontol B Psychol Sci Soc Sci. 2010 Sep;65(5):591-8. doi: 10.1093/geronb/gbp117. Epub 2009 Dec 11.

Aiken Morgan AT, Marsiske M, Dzierzewski JM, Jones RN, Whitfield KE, Johnson KE, Cresci MK. Race-related cognitive test bias in the active study: a mimic model approach. Exp Aging Res. 2010 Oct;36(4):426-52. doi: 10.1080/0361073X.2010.507427.

Gross AL, Rebok GW, Unverzagt FW, Willis SL, Brandt J. Word list memory predicts everyday function and problem-solving in the elderly: results from the ACTIVE cognitive intervention trial. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2011 Mar;18(2):129-46. doi: 10.1080/13825585.2010.516814. Epub 2010 Nov 10.

Ball K, Edwards JD, Ross LA, McGwin G Jr. Cognitive training decreases motor vehicle collision involvement of older drivers. J Am Geriatr Soc. 2010 Nov;58(11):2107-13. doi: 10.1111/j.1532-5415.2010.03138.x.

Parisi JM, Gross AL, Rebok GW, Saczynski JS, Crowe M, Cook SE, Langbaum JB, Sartori A, Unverzagt FW. Modeling change in memory performance and memory perceptions: findings from the ACTIVE study. Psychol Aging. 2011 Sep;26(3):518-24. doi: 10.1037/a0022458.

O'Connor ML, Edwards JD, Small BJ, Andel R. Patterns of level and change in self-reported driving behaviors among older adults: who self-regulates? J Gerontol B Psychol Sci Soc Sci. 2012 Jul;67(4):437-46. doi: 10.1093/geronb/gbr122. Epub 2011 Dec 1.

Gross AL, Rebok GW. Memory training and strategy use in older adults: results from the ACTIVE study. Psychol Aging. 2011 Sep;26(3):503-17. doi: 10.1037/a0022687.

Gross AL, Rebok GW, Unverzagt FW, Willis SL, Brandt J. Cognitive predictors of everyday functioning in older adults: results from the ACTIVE Cognitive Intervention Trial. J Gerontol B Psychol Sci Soc Sci. 2011 Sep;66(5):557-66. doi: 10.1093/geronb/gbr033. Epub 2011 May 9.

Unverzagt FW, Guey LT, Jones RN, Marsiske M, King JW, Wadley VG, Crowe M, Rebok GW, Tennstedt SL. ACTIVE cognitive training and rates of incident dementia. J Int Neuropsychol Soc. 2012 Jul;18(4):669-77. doi: 10.1017/S1355617711001470. Epub 2012 Mar 9.

Sisco SM, Marsiske M. Neighborhood Influences on Late Life Cognition in the ACTIVE Study. J Aging Res. 2012;2012:435826. doi: 10.1155/2012/435826. Epub 2012 Aug 26.

Gross AL, Inouye SK, Rebok GW, Brandt J, Crane PK, Parisi JM, Tommet D, Bandeen-Roche K, Carlson MC, Jones RN. Parallel but not equivalent: challenges and solutions for repeated assessment of cognition over time. J Clin Exp Neuropsychol. 2012;34(7):758-72. doi: 10.1080/13803395.2012.681628. Epub 2012 Apr 30.

Gross AL, Rebok GW, Brandt J, Tommet D, Marsiske M, Jones RN. Modeling learning and memory using verbal learning tests: results from ACTIVE. J Gerontol B Psychol Sci Soc Sci. 2013 Mar;68(2):153-67. doi: 10.1093/geronb/gbs053. Epub 2012 Aug 28.

Sartori AC, Wadley VG, Clay OJ, Parisi JM, Rebok GW, Crowe M. The relationship between cognitive function and life space: the potential role of personal control beliefs. Psychol Aging. 2012 Jun;27(2):364-74. doi: 10.1037/a0025212. Epub 2011 Aug 29.

Lin F, Chen DG, Vance DE, Ball KK, Mapstone M. Longitudinal relationships between subjective fatigue, cognitive function, and everyday functioning in old age. Int Psychogeriatr. 2013 Feb;25(2):275-85. doi: 10.1017/S1041610212001718. Epub 2012 Oct 19.

Responsible Party:	New England Research Institutes
ClinicalTrials.gov Identifier:	NCT00298558 History of Changes
Other Study ID Numbers:	IA0091 U01NR004507 ( US NIH Grant/Contract Award Number ) U01NR004508 ( US NIH Grant/Contract Award Number ) U01AG014260 ( US NIH Grant/Contract Award Number ) U01AG014282 ( US NIH Grant/Contract Award Number ) U01AG014263 ( US NIH Grant/Contract Award Number ) U01AG014289 ( US NIH Grant/Contract Award Number ) U01AG014276 ( US NIH Grant/Contract Award Number )
Study First Received:	February 28, 2006
Results First Received:	April 24, 2013
Last Updated:	March 24, 2014
Health Authority:	United States: Federal Government

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