Trial · NCT01084135

Rivastigmine Study in Adolescents With Down Syndrome

NCT01084135, Phase 1, Phase 2, Completed, Duke University; results first posted 2015-03-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rivastigmine Study in Adolescents With Down Syndrome. Trials, record NCT01084135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01084135

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rivastigmine Study in Adolescents With Down Syndrome
NCT number: NCT01084135
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 42 participants, actual
Lead sponsor: Duke University
Conditions: Down Syndrome
Interventions: Rivastigmine, Liquid Placebo
First posted: 2010-03-10
Last updated: 2015-04-06
Results first posted: 2015-03-12

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)	Baseline & Study termination (Week 20)	The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject's ABC at Baseline and the Final Visit was computed. A rise in standard scores from Baseline to the Final Visit indicates improvement.
Secondary	Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)	Baseline and Final (Week 20) visit	The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting. It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales. Raw scores range from 63 to 189. Higher scores suggest that an individual's executive function skills are more problematic. In this study, the change between each subject's raw score at Baseline and the Final Visit was computed for the Global Executive Composite. A decline in raw scores from Baseline to the Final Visit indicates improvement.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)	Baseline & Study termination (Week 20)	All subjects who completed the 20 week period were included in analysis except for 2 subjects whose form was completed incorrectly.	units on a scale	MEAN
SECONDARY	Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)	Baseline and Final (Week 20) visit	All subjects who completed the 20 week period were included in analysis except for 1 subjects whose form was completed incorrectly.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)	Rivastigmine- Liquid Form	-1.7	Standard Deviation 3.2	units on a scale
Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)	Liquid Placebo	2.0	Standard Deviation 3.6	units on a scale
Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)	Rivastigmine- Liquid Form	-3.6	Standard Deviation 7.7	units on a scale
Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)	Liquid Placebo	-6.1	Standard Deviation 12.0	units on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
12 Week	STARTED	Rivastigmine- Liquid Form	4
12 Week	STARTED	Liquid Placebo	4
12 Week	COMPLETED	Rivastigmine- Liquid Form	4
12 Week	COMPLETED	Liquid Placebo	4
12 Week	NOT COMPLETED	Rivastigmine- Liquid Form	0
12 Week	NOT COMPLETED	Liquid Placebo	0
20 Week	STARTED	Rivastigmine- Liquid Form	12
20 Week	STARTED	Liquid Placebo	11
20 Week	COMPLETED	Rivastigmine- Liquid Form	12
20 Week	COMPLETED	Liquid Placebo	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events172

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	20 Week: Rivastigmine- Liquid Form	3	12
other	Diarrhea	Gastrointestinal disorders	20 Week: Liquid Placebo	2	11
other	Diarrhea	Gastrointestinal disorders	12 Week: Rivastigmine- Liquid Form	0	4
other	Diarrhea	Gastrointestinal disorders	12 Week: Liquid Placebo	3	4
other	Nausea	Gastrointestinal disorders	20 Week: Rivastigmine- Liquid Form	3	12
other	Nausea	Gastrointestinal disorders	20 Week: Liquid Placebo	3	11
other	Nausea	Gastrointestinal disorders	12 Week: Rivastigmine- Liquid Form	1	4
other	Nausea	Gastrointestinal disorders	12 Week: Liquid Placebo	1	4
other	Stomach ache	Gastrointestinal disorders	20 Week: Rivastigmine- Liquid Form	5	12
other	Stomach ache	Gastrointestinal disorders	20 Week: Liquid Placebo	3	11

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	20 Week: Rivastigmine- Liquid Form
Total, all-cause mortality	20 Week: Liquid Placebo
Total, all-cause mortality	12 Week: Rivastigmine- Liquid Form
Total, all-cause mortality	12 Week: Liquid Placebo
Total, other adverse events	20 Week: Rivastigmine- Liquid Form	11	12
Total, other adverse events	20 Week: Liquid Placebo	8	11
Total, other adverse events	12 Week: Rivastigmine- Liquid Form	3	4
Total, other adverse events	12 Week: Liquid Placebo	4	4
Total, serious adverse events	20 Week: Rivastigmine- Liquid Form	0	12
Total, serious adverse events	20 Week: Liquid Placebo	0	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01084135

GET https://conductscience.org/api/trials/v1/NCT01084135/events?page=2

API reference For AI assistants