Trial · NCT00703677
A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
NCT00703677, Phase 1, Phase 2, Completed, Westat; results first posted 2010-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration. Trials, record NCT00703677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703677
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
- NCT number
- NCT00703677
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Westat
- Conditions
- Progressive Supranuclear Palsy, Corticobasal Degeneration
- Interventions
- Lithium
- First posted
- 2008-06-23
- Last updated
- 2024-05-17
- Results first posted
- 2010-06-11
- Limitations and caveats
- The majority of subjects did not tolerate study drug, therefore, evaluations of subjects on study drug are limited in number.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ability to Tolerate Lithium Carbonate | 28 weeks | The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L. |
| Secondary | Study Drug Compliance | 28 weeks | Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant. |
| Secondary | Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF) | 28 weeks | Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28. |
| Secondary | Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF | 28 weeks | With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28. |
| Secondary | Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity | 28 weeks | Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28 |
| Secondary | PSP Rating Scale Score: Change From Baseline | 28 weeks | The PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28. |
| Secondary | Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline | 28 weeks | The UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28. |
| Secondary | PSP-Quality of Life Scale (QoL):Change From Baseline | 28 weeks | The PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28. |
| Secondary | Frontal Assessment Battery (FAB): Change From Baseline | 28 weeks | The FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28. |
| Secondary | Geriatric Depression Scale(GDS)-15:Change From Baseline | 28 weeks | The GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ability to Tolerate Lithium Carbonate | 28 weeks | One subject completed the full 28 week course of study drug; 13 subjects stopped drug early due to intolerability. | Subject | NUMBER |
| SECONDARY | Study Drug Compliance | 28 weeks | All subjects were evaluated for compliance. | Subjects | NUMBER |
| SECONDARY | Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF) | 28 weeks | Due to the very small number of samples collected, samples were not analyzed | ||
| SECONDARY | Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF | 28 weeks | Due to the very small number of samples collected, samples were not analyzed | ||
| SECONDARY | Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity | 28 weeks | Due to the very small number of samples collected, samples were not analyzed. | ||
| SECONDARY | PSP Rating Scale Score: Change From Baseline | 28 weeks | |||
| SECONDARY | Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline | 28 weeks | |||
| SECONDARY | PSP-Quality of Life Scale (QoL):Change From Baseline | 28 weeks | |||
| SECONDARY | Frontal Assessment Battery (FAB): Change From Baseline | 28 weeks | |||
| SECONDARY | Geriatric Depression Scale(GDS)-15:Change From Baseline | 28 weeks |
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 |
|---|---|---|---|---|---|
| Ability to Tolerate Lithium Carbonate | Lithium Carbonate | 1 | Subject | ||
| Study Drug Compliance | Lithium Carbonate | 14 | Subjects |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lithium Carbonate | 17 | |
| Overall Study | COMPLETED | Lithium Carbonate | 14 | |
| Overall Study | NOT COMPLETED | Lithium Carbonate | 3 |
Source ClinicalTrials.gov
Adverse events74
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 | Fatigue | General disorders | Lithium Carbonate | 5 | 17 | 8 |
| other | Eyelid oedema | Eye disorders | Lithium Carbonate | 1 | 17 | 1 |
| other | Constipation | Gastrointestinal disorders | Lithium Carbonate | 1 | 17 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Lithium Carbonate | 1 | 17 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Lithium Carbonate | 2 | 17 | 3 |
| other | Nausea | Gastrointestinal disorders | Lithium Carbonate | 1 | 17 | 1 |
| other | Asthenia | General disorders | Lithium Carbonate | 4 | 17 | 6 |
| other | Gait disturbance/Balance disorder | Nervous system disorders | Lithium Carbonate | 9 | 17 | 16 |
| other | Oedema peripheral | General disorders | Lithium Carbonate | 1 | 17 | 1 |
| other | Urinary tract infection | Infections and infestations | Lithium Carbonate | 5 | 17 | 5 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium Carbonate | ||
| Total, other adverse events | Lithium Carbonate | 17 | 17 |
| Total, serious adverse events | Lithium Carbonate | 4 | 17 |
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 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.
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/NCT00703677
GET https://conductscience.org/api/trials/v1/NCT00703677/events?page=2