Trial Outcomes & Findings for Cognitive Decline in Non-demented PD (NCT NCT01340885)

NCT ID: NCT01340885

Last Updated: 2020-07-07

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-07-07

Participant Flow

Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.

Participant milestones

Participant milestones
Measure
Atomoxetine
Strattera 10-30 mg b.i.d. Strattera: 10-30 mg b.i.d. for 6 weeks
Rivastigimine
Exelon 1.5-4.5 mg b.i.d. Exelon: 1.5-4.5 mg b.i.d. for 6 weeks
Placebo
sugar pill Placebo: 2-6 pills for 6 weeks
Overall Study
STARTED
0
0
0
Overall Study
COMPLETED
0
0
0
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Decline in Non-demented PD

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6 weeks

Population: Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.

PDQ-39

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.

Outcome measures

Outcome data not reported

Adverse Events

Atomoxetine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Rivastigimine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diana Dimitrova

Oregon Health & Science University

Phone: 503-494-7269

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place