Trial · NCT02118727

Therapy in Amyotrophic Lateral Sclerosis (TAME)

NCT02118727, Phase 2, Completed, University of Kansas Medical Center; results first posted 2022-11-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Therapy in Amyotrophic Lateral Sclerosis (TAME). Trials, record NCT02118727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02118727

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Trial

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

Title: Therapy in Amyotrophic Lateral Sclerosis (TAME)
NCT number: NCT02118727
Status: Completed
Phases: Phase 2
Enrollment: 89 participants, actual
Lead sponsor: University of Kansas Medical Center
Conditions: Amyotrophic Lateral Sclerosis, Frontal Temporal Dementia
Interventions: Memantine, Placebo (for Memantine)
First posted: 2014-04-21
Last updated: 2022-11-29
Results first posted: 2022-11-29

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks.	During 36 weeks of therapy	The primary outcome measure will be disease progression as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) during the 36 weeks of therapy. The patient's rate of progression on active therapy during the 36 week treatment arm will be compared to the rate of progression of the placebo arm. The ALSFRS-R is a 12 question rating scale used to determine each participant's assessment of their capability and independence in daily activities. Possible values are from 0 to 48; higher score means better outcome.
Other	Measuring the Levels of Tau, Phosphorylated Neurofilament Heavy Chain (pNFH) and the pNFH/C3 Ratio in Blood	36 weeks of treatment	Preliminary data have demonstrated that there are elevated levels of Tau and pNF-H in the blood of patients with ALS as compared to healthy controls suggesting that these proteins could also be used for measuring a patient's disease progression.
Other	Slowing of Behavioral Decline in Those With FTD Characteristics Based on the NPI-Q and the ALS-Cognitive Behavioral Screen (CBS)™	36 weeks of treatment	The ALS Cognitive Behavioral Screen (ALS-CBS™) and the Neuropsychiatric Inventory Questionnaire (NPI-Q), are two neuropsychological batteries that are validated measurements of frontotemporal dementia (FTD). The ALS-CBS questionnaire rates changes perceived in the patient by the caregiver. Possible values for the Cognitive score are from 0-20, and for the Behavior score are from 0-45. A higher score means better outcome. The NPI-Q provides an informant-based assessment of neuropsychiatric symptoms and associated caregiver distress for evaluating psychopathology in dementia. Possible values for the 12 item Total NPI score are from 0-36, and for the 12 item Total Distress score are from 0-30. A lower score means a better outcome

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks.	During 36 weeks of therapy	Includes the 54/58 participants randomized to memantine and 29/31 participants randomized to placebo with more than one ALSFRS-R value.	score on a scale/week	MEAN
OTHER_PRE_SPECIFIED	Measuring the Levels of Tau, Phosphorylated Neurofilament Heavy Chain (pNFH) and the pNFH/C3 Ratio in Blood	36 weeks of treatment
OTHER_PRE_SPECIFIED	Slowing of Behavioral Decline in Those With FTD Characteristics Based on the NPI-Q and the ALS-Cognitive Behavioral Screen (CBS)™	36 weeks of treatment

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks.	Memantine		-0.290	Standard Error 0.39	score on a scale/week
The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks.	Placebo		-0.281	Standard Error 0.32	score on a scale/week

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Memantine	58
Overall Study	STARTED	Placebo	31
Overall Study	COMPLETED	Memantine	33
Overall Study	COMPLETED	Placebo	20
Overall Study	NOT COMPLETED	Memantine	25
Overall Study	NOT COMPLETED	Placebo	11

Source ClinicalTrials.gov

Adverse events66

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	Events
other	Confusion	Psychiatric disorders	Memantine	10	58	10
other	Confusion	Psychiatric disorders	Placebo	1	31	1
other	Constipation	Gastrointestinal disorders	Memantine	8	58	8
other	Constipation	Gastrointestinal disorders	Placebo	5	31	7
other	Diarrhea	Gastrointestinal disorders	Memantine	3	58	3
other	Diarrhea	Gastrointestinal disorders	Placebo	1	31	1
other	Dizziness	Nervous system disorders	Memantine	15	58	18
other	Dizziness	Nervous system disorders	Placebo	2	31	2
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Memantine	4	58	6
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Placebo	2	31	2

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Memantine	3	58
Total, all-cause mortality	Placebo	3	31
Total, other adverse events	Memantine	46	58
Total, other adverse events	Placebo	19	31
Total, serious adverse events	Memantine	8	58
Total, serious adverse events	Placebo	3	31

Source ClinicalTrials.gov

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 comparisons2

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

Comparison	Source
Memantine vs Placebo: deaths from any cause	Trial comparisons
Memantine vs Placebo: serious adverse events	Trial comparisons

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/NCT02118727

GET https://conductscience.org/api/trials/v1/NCT02118727/events?page=2

API reference For AI assistants