← Trials/Trial dossier/NCT00975481
CompletedPhase 1Results posted
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
A Randomized, Double-Blind, Placebo- And Active-Controlled Single-Dose, Crossover Study To Evaluate The Abuse Potential Of Single Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Lead sponsor
Asset
Dimebon
Listed sites
0
Recruiting sites
-
Enrollment
36
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 18-55
Primary endpoints
•Balance of Effects- Drug Liking VAS•Balance of Effects- Overall Drug Liking VAS•Balance of Effects- Take Drug Again VAS
Identifiers
Registered as
Org study IDB1451037
NCT IDNCT00975481
Timeline
Milestones
Study first posted2009-09-11estimated
Study start2009-10 (month precision)
Primary completion2010-02actual (month precision)
Study completion2010-02actual (month precision)
Last update posted2013-04-02estimated
Results first posted2013-04-02estimated
Assets
Drug assets
Study populations
Who this study enrolls
Alzheimer’s disease
Eligibility
Who can enroll
Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Healthy male and/or female subjects between the ages of 18 and 55 years.
•Recreational polydrug user with a history of CNS depressant use
Exclusion criteria
•History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
•A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
•Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
•History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.
Endpoints (30)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Other (unclassified)
30 endpointsPrimary/protocol endpoint/low confidence
Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
Time frame:6, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])
Time frame:6, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)
Time frame:6, 12, 24 hrs post-dose
descriptive
Primary/protocol endpoint/low confidence
Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Other Subjective Effects- Drug Similarity
Time frame:12 hours post-dose
descriptive
Primary/protocol endpoint/low confidence
Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Primary/registry result/low confidence
Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| PlaceboEmaxn=32 Participants | 57.8 | 10.03 |
| Eminn=32 Participants | 47.0 | 9.38 |
| Alprazolam 1 mgEmaxn=33 Participants | 78.6 | 17.53 |
| Eminn=33 Participants | 45.4 | 11.21 |
| Alprazolam 3 mgEmaxn=34 Participants | 82.2 | 14.55 |
| Eminn=34 Participants | 37.4 | 17.32 |
| Dimebon 20 mgEmaxn=33 Participants | 57.2 | 11.76 |
| Eminn=33 Participants | 48.4 | 8.89 |
| Dimebon 40 mgEmaxn=32 Participants | 55.8 | 9.41 |
| Eminn=32 Participants | 49.0 | 3.59 |
| Dimebon 60 mgEmaxn=31 Participants | 58.5 | 12.54 |
| Eminn=31 Participants | 46.5 | 10.44 |
Mean Difference (Final Values)20.809695% CI15.0866 - 26.5327p<0.0001Mixed Models Analysis
Mean Difference (Final Values)24.462595% CI18.7321 - 30.1929p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-0.579295% CI-6.3385 - 5.1800p0.8428Mixed Models Analysis
Mean Difference (Final Values)-1.999395% CI-7.7832 - 3.7845p0.4957Mixed Models Analysis
Mean Difference (Final Values)0.968395% CI-4.8567 - 6.7932p0.7431Mixed Models Analysis
Mean Difference (Final Values)-21.388995% CI-27.1044 - -15.6734p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-22.809095% CI-28.5584 - -17.0596p<0.0001Mixed Models Analysis
Median Difference (Final Values)-19.841495% CI-25.6435 - -14.0393p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-25.041895% CI-30.6705 - -19.4130p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-26.461895% CI-32.1455 - -20.7782p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-23.494395% CI-29.2440 - -17.7445p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-1.453895% CI-6.5274 - 3.6198p0.5720Mixed Models Analysis
Mean Difference (Final Values)-8.993895% CI-14.0695 - -3.9180p0.0006Mixed Models Analysis
Mean Difference (Final Values)1.868695% CI-3.2342 - 6.9713p0.4704Mixed Models Analysis
Mean Difference (Final Values)2.072595% CI-3.0533 - 7.1984p0.4255Mixed Models Analysis
Mean Difference (Final Values)-0.342595% CI-5.5053 - 4.8204p0.8959Mixed Models Analysis
Mean Difference (Final Values)3.322495% CI-1.7402 - 8.3850p0.1967Mixed Models Analysis
Mean Difference (Final Values)3.526495% CI-1.5676 - 8.6203p0.1733Mixed Models Analysis
Mean Difference (Final Values)1.111395% CI-4.0285 - 6.2512p0.6697Mixed Models Analysis
Mean Difference (Final Values)10.862395% CI5.8712 - 15.8535p<0.0001Mixed Models Analysis
Mean Difference (Final Values)11.066395% CI6.0281 - 16.1045p<0.0001Mixed Models Analysis
Mean Difference (Final Values)8.651395% CI3.5552 - 13.7474p0.0010Mixed Models Analysis
Primary/registry result/low confidence
Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
Time frame:6, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| PlaceboEmaxn=32 Participants | 57.8 | 14.31 |
| Eminn=32 Participants | 52.5 | 9.13 |
| Alprazolam 1 mgEmaxn=33 Participants | 74.6 | 18.99 |
| Eminn=33 Participants | 64.5 | 20.17 |
| Alprazolam 3 mgEmaxn=34 Participants | 78.0 | 15.50 |
| Eminn=34 Participants | 62.6 | 18.13 |
| Dimebon 20 mgEmaxn=33 Participants | 56.5 | 11.44 |
| Eminn=33 Participants | 48.2 | 15.96 |
| Dimebon 40 mgEmaxn=32 Participants | 55.4 | 11.29 |
| Eminn=32 Participants | 52.0 | 8.75 |
| Dimebon 60 mgEmaxn=31 Participants | 58.1 | 12.52 |
| Eminn=31 Participants | 51.1 | 8.94 |
Mean Difference (Final Values)16.638895% CI10.5727 - 22.7049p<0.0001Mixed Models Analysis
Mean Difference (Final Values)19.843295% CI13.7627 - 25.9238p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-1.612195% CI-7.7209 - 4.4967p0.6029Mixed Models Analysis
Mean Difference (Final Values)-2.924195% CI-9.0571 - 3.2089p0.3477Mixed Models Analysis
Mean Difference (Final Values)0.090895% CI-6.0850 - 6.2667p0.9769Mixed Models Analysis
Mean Difference (Final Values)-18.250995% CI-24.3155 - -12.1864p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-19.562995% CI-25.6616 - -13.4642p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-16.548095% CI-22.7036 - -10.3923p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-21.455495% CI-27.4199 - -15.4908p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-22.767395% CI-28.7925 - -16.7422p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-19.752495% CI-25.8485 - -13.6563p<0.0001Mixed Models Analysis
Mean Difference (Final Values)12.088895% CI5.3225 - 18.8551p0.0006Mixed Models Analysis
Mean Difference (Final Values)10.076895% CI3.3132 - 16.8403p0.0038Mixed Models Analysis
Mean Difference (Final Values)-4.187595% CI-10.9890 - 2.6139p0.2257Mixed Models Analysis
Mean Difference (Final Values)-0.858995% CI-7.6927 - 5.9750p0.8042Mixed Models Analysis
Mean Difference (Final Values)-1.633595% CI-8.5177 - 5.2506p0.6399Mixed Models Analysis
Mean Difference (Final Values)-16.276395% CI-23.0228 - -9.5229p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-12.947795% CI-19.7374 - -6.1580p0.0002Mixed Models Analysis
Mean Difference (Final Values)-13.722395% CI-20.5720 - -6.8727p0.0001Mixed Models Analysis
Mean Difference (Final Values)-14.264395% CI-20.9226 - -7.6060p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-10.935695% CI-17.6548 - -4.2165p0.0016Mixed Models Analysis
Mean Difference (Final Values)-11.710395% CI-18.5055 - -4.9151p0.0008Mixed Models Analysis
Primary/registry result/low confidence
Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])
Time frame:6, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 53.9 | 22.30 |
| Alprazolam 1 mgn=33 Participants | 77.5 | 22.26 |
| Alprazolam 3 mgn=34 Participants | 83.2 | 15.99 |
| Dimebon 20 mgn=33 Participants | 47.6 | 28.66 |
| Dimebon 40 mgn=32 Participants | 50.4 | 26.23 |
| Dimebon 60 mgn=31 Participants | 52.5 | 25.66 |
Mean Difference (Final Values)24.009095% CI13.7265 - 34.2916p<0.0001Mixed Models Analysis
Mean Difference (Final Values)29.415695% CI19.1160 - 39.7151p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-6.397995% CI-16.7479 - 3.9521p0.2239Mixed Models Analysis
Mean Difference (Final Values)-4.139695% CI-14.5328 - 6.2526p0.4326Mixed Models Analysis
Mean Difference (Final Values)-1.728395% CI-12.1950 - 8.7383p0.7447Mixed Models Analysis
Mean Difference (Final Values)-30.406995% CI-40.6795 - -20.1343p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-28.148795% CI-38.4812 - -17.8161p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-25.737495% CI-36.1651 - -15.3096p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-35.813495% CI-45.9257 - -25.7012p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-33.555295% CI-43.7675 - -23.3429p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-31.143995% CI-41.4754 - -20.8124p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| PlaceboEmaxn=32 Participants | 56.2 | 7.15 |
| Eminn=32 Participants | 48.0 | 8.83 |
| Alprazolam 1 mgEmaxn=33 Participants | 80.9 | 15.93 |
| Eminn=33 Participants | 46.7 | 10.70 |
| Alprazolam 3 mgEmaxn=34 Participants | 81.9 | 14.40 |
| Eminn=34 Participants | 38.6 | 15.76 |
| Dimebon 20 mgEmaxn=33 Participants | 57.9 | 13.53 |
| Eminn=33 Participants | 49.3 | 2.79 |
| Dimebon 40 mgEmaxn=32 Participants | 56.6 | 11.21 |
| Eminn=32 Participants | 48.3 | 8.82 |
| Dimebon 60 mgEmaxn=31 Participants | 57.6 | 8.92 |
| Eminn=31 Participants | 48.9 | 3.03 |
Mean Difference (Final Values)24.877995% CI19.5658 - 30.1899p<0.0001Mixed Models Analysis
Mean Difference (Final Values)25.985795% CI20.6670 - 31.3043p<0.0001Mixed Models Analysis
Mean Difference (Final Values)2.054495% CI-3.2911 - 7.3998p0.4489Mixed Models Analysis
Mean Difference (Final Values)0.574395% CI-4.7941 - 5.9427p0.8329Mixed Models Analysis
Mean Difference (Final Values)1.686395% CI-3.7203 - 7.0929p0.5387Mixed Models Analysis
Mean Difference (Final Values)-22.823595% CI-28.1283 - -17.5187p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-24.303695% CI-29.6400 - -18.9672p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-23.191695% CI-28.5768 - -17.8064p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-23.931395% CI-29.1559 - -18.7066p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-25.411495% CI-30.6869 - -20.1358p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-24.299495% CI-29.6361 - -18.9626p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-1.430195% CI-5.9725 - 3.1123p0.5349Mixed Models Analysis
Mean Difference (Final Values)-9.136795% CI-13.6684 - -4.6050p0.0001Mixed Models Analysis
Mean Difference (Final Values)1.335795% CI-3.2244 - 5.8958p0.5637Mixed Models Analysis
Mean Difference (Final Values)0.406595% CI-4.1779 - 4.9909p0.8612Mixed Models Analysis
Mean Difference (Final Values)0.917595% CI-3.7022 - 5.5373p0.6954Mixed Models Analysis
Mean Difference (Final Values)2.765895% CI-1.7552 - 7.2868p0.2287Mixed Models Analysis
Mean Difference (Final Values)1.836695% CI-2.7158 - 6.3890p0.4267Mixed Models Analysis
Mean Difference (Final Values)2.347695% CI-2.2429 - 6.9381p0.3140Mixed Models Analysis
Mean Difference (Final Values)10.472495% CI5.9992 - 14.9456p<0.0001Mixed Models Analysis
Mean Difference (Final Values)9.543295% CI5.0320 - 14.0544p<0.0001Mixed Models Analysis
Mean Difference (Final Values)10.054295% CI5.4940 - 14.6144p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)
Time frame:6, 12, 24 hrs post-dose
descriptive
Posted result
| Group | Value (mean), Dollar | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 4.805 | 9.7833 |
| Alprazolam 1 mgn=33 Participants | 19.621 | 16.2519 |
| Alprazolam 3 mgn=34 Participants | 25.551 | 17.0192 |
| Dimebon 20 mgn=33 Participants | 6.098 | 12.3269 |
| Dimebon 40 mgn=32 Participants | 3.836 | 6.5345 |
| Dimebon 60 mgn=31 Participants | 4.573 | 9.8211 |
Mean Difference (Final Values)14.472895% CI9.4718 - 19.4737p<0.0001Mixed Models Analysis
Mean Difference (Final Values)19.728495% CI14.7131 - 24.7437p<0.0001Mixed Models Analysis
Mean Difference (Final Values)0.208895% CI-4.8289 - 5.2466p0.9348Mixed Models Analysis
Mean Difference (Final Values)-1.727195% CI-6.7841 - 3.3299p0.5009Mixed Models Analysis
Mean Difference (Final Values)-0.332595% CI-5.4245 - 4.7595p0.8975Mixed Models Analysis
Mean Difference (Final Values)-14.264095% CI-19.2660 - -9.2619p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-16.199995% CI-21.2294 - -11.1704p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-14.805395% CI-19.8822 - -9.7283p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-19.519595% CI-24.4361 - -14.6030p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-21.455595% CI-26.4230 - -16.4880p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-20.060995% CI-25.0872 - -15.0345p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), Units on scale | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 3.2 | 2.51 |
| Alprazolam 1 mgn=33 Participants | 6.2 | 4.16 |
| Alprazolam 3 mgn=34 Participants | 8.1 | 4.37 |
| Dimebon 20 mgn=33 Participants | 3.5 | 3.10 |
| Dimebon 40 mgn=32 Participants | 3.6 | 3.22 |
| Dimebon 60 mgn=31 Participants | 3.5 | 2.87 |
Mean Difference (Final Values)3.163495% CI1.9014 - 4.4254p<0.0001Mixed Models Analysis
Mean Difference (Final Values)4.670695% CI3.4066 - 5.9346p<0.0001Mixed Models Analysis
Mean Difference (Final Values)0.147895% CI-1.1217 - 1.4173p0.8184Mixed Models Analysis
Mean Difference (Final Values)0.221195% CI-1.0540 - 1.4963p0.7324Mixed Models Analysis
Mean Difference (Final Values)0.094695% CI-1.1898 - 1.3791p0.8844Mixed Models Analysis
Mean Difference (Final Values)-3.015695% CI-4.2754 - -1.7558p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-2.942395% CI-4.2101 - -1.6745p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-3.068895% CI-4.3484 - -1.7891p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-4.522895% CI-5.7651 - -3.2805p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-4.449595% CI-5.7031 - -3.1959p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-4.576095% CI-5.8438 - -3.3081p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 35.2 | 31.94 |
| Alprazolam 1 mgn=33 Participants | 81.2 | 18.16 |
| Alprazolam 3 mgn=34 Participants | 84.7 | 14.32 |
| Dimebon 20 mgn=33 Participants | 34.4 | 32.87 |
| Dimebon 40 mgn=32 Participants | 32.0 | 32.33 |
| Dimebon 60 mgn=31 Participants | 39.7 | 31.34 |
Mean Difference (Final Values)46.079895% CI34.0453 - 58.1142p<0.0001Mixed Models Analysis
Mean Difference (Final Values)49.877195% CI37.8247 - 61.9295p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-0.579795% CI-12.6918 - 11.5325p0.9248Mixed Models Analysis
Mean Difference (Final Values)-3.363295% CI-15.5264 - 8.8000p0.5857Mixed Models Analysis
Mean Difference (Final Values)4.422595% CI-7.8270 - 16.6719p0.4768Mixed Models Analysis
Mean Difference (Final Values)-46.659495% CI-58.6804 - -34.6385p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-49.443095% CI-61.5346 - -37.3514p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-41.657395% CI-53.8600 - -29.4546p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-50.456795% CI-62.2925 - -38.6210p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-53.240395% CI-65.1923 - -41.2882p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-45.454695% CI-57.5459 - -33.3633p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 30.4 | 30.22 |
| Alprazolam 1 mgn=33 Participants | 77.1 | 24.93 |
| Alprazolam 3 mgn=34 Participants | 88.0 | 13.13 |
| Dimebon 20 mgn=33 Participants | 25.9 | 28.39 |
| Dimebon 40 mgn=32 Participants | 29.9 | 33.07 |
| Dimebon 60 mgn=31 Participants | 35.8 | 32.44 |
Mean Difference (Final Values)46.845095% CI34.6464 - 59.0436p<0.0001Mixed Models Analysis
Mean Difference (Final Values)57.501395% CI45.3036 - 69.6991p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-5.091395% CI-17.3421 - 7.1595p0.4129Mixed Models Analysis
Mean Difference (Final Values)-1.189395% CI-13.4954 - 11.1168p0.8488Mixed Models Analysis
Mean Difference (Final Values)5.199595% CI-7.1963 - 17.5954p0.4086Mixed Models Analysis
Mean Difference (Final Values)-51.936395% CI-64.1108 - -39.7618p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-48.034395% CI-60.2801 - -35.7885p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-41.645595% CI-53.9964 - -29.2946p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-62.592695% CI-74.5881 - -50.5971p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-58.690695% CI-70.7965 - -46.5847p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-52.301895% CI-64.5427 - -40.0609p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 17.2 | 24.38 |
| Alprazolam 1 mgn=33 Participants | 33.9 | 29.88 |
| Alprazolam 3 mgn=34 Participants | 44.6 | 23.58 |
| Dimebon 20 mgn=33 Participants | 15.9 | 25.38 |
| Dimebon 40 mgn=32 Participants | 16.8 | 24.27 |
| Dimebon 60 mgn=31 Participants | 19.7 | 25.47 |
Mean Difference (Final Values)16.460495% CI6.3210 - 26.5998p0.0016Mixed Models Analysis
Mean Difference (Final Values)27.997195% CI17.8247 - 38.1696p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-1.142595% CI-11.3591 - 9.0742p0.8254Mixed Models Analysis
Mean Difference (Final Values)0.747095% CI-9.5075 - 11.0015p0.8858Mixed Models Analysis
Mean Difference (Final Values)3.427995% CI-6.8972 - 13.7529p0.5128Mixed Models Analysis
Mean Difference (Final Values)-17.602895% CI-27.7485 - -7.4572p0.0008Mixed Models Analysis
Mean Difference (Final Values)-15.713495% CI-25.9136 - -5.5132p0.0028Mixed Models Analysis
Mean Difference (Final Values)-13.032595% CI-23.3295 - -2.7355p0.0135Mixed Models Analysis
Mean Difference (Final Values)-29.139695% CI-39.1071 - -19.1721p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-27.250295% CI-37.3224 - -17.1780p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-24.569395% CI-34.7614 - -14.3772p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), Units on Scale | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 3.8 | 1.83 |
| Alprazolam 1 mgn=33 Participants | 4.9 | 1.76 |
| Alprazolam 3 mgn=34 Participants | 7.0 | 2.57 |
| Dimebon 20 mgn=33 Participants | 3.8 | 1.42 |
| Dimebon 40 mgn=32 Participants | 3.8 | 1.50 |
| Dimebon 60 mgn=31 Participants | 3.6 | 1.58 |
Mean Difference (Final Values)1.253595% CI0.5623 - 1.9446p0.0005Mixed Models Analysis
Mean Difference (Final Values)3.501095% CI2.8073 - 4.1948p<0.0001Mixed Models Analysis
Mean Difference (Final Values)0.341895% CI-0.3559 - 1.0396p0.3347Mixed Models Analysis
Mean Difference (Final Values)0.320895% CI-0.3808 - 1.0225p0.3678Mixed Models Analysis
Mean Difference (Final Values)0.036095% CI-0.6686 - 0.7406p0.9197Mixed Models Analysis
Mean Difference (Final Values)-0.911795% CI-1.6013 - -0.2220p0.0099Mixed Models Analysis
Mean Difference (Final Values)-0.932695% CI-1.6269 - -0.2384p0.0088Mixed Models Analysis
Mean Difference (Final Values)-1.217595% CI-1.9171 - -0.5178p0.0008Mixed Models Analysis
Mean Difference (Final Values)-3.159295% CI-3.8380 - -2.4804p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-3.180295% CI-3.8656 - -2.4947p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-3.465095% CI-4.1583 - -2.7717p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), Units on Scale | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 4.7 | 2.57 |
| Alprazolam 1 mgn=33 Participants | 9.9 | 3.51 |
| Alprazolam 3 mgn=34 Participants | 11.5 | 2.48 |
| Dimebon 20 mgn=33 Participants | 5.3 | 3.26 |
| Dimebon 40 mgn=32 Participants | 5.5 | 2.75 |
| Dimebon 60 mgn=31 Participants | 5.5 | 2.75 |
Mean Difference (Final Values)5.294395% CI4.0783 - 6.5102p<0.0001Mixed Models Analysis
Mean Difference (Final Values)6.898395% CI5.6799 - 8.1167p<0.0001Mixed Models Analysis
Mean Difference (Final Values)0.654595% CI-0.5676 - 1.8767p0.2917Mixed Models Analysis
Mean Difference (Final Values)0.848995% CI-0.3784 - 2.0763p0.1738Mixed Models Analysis
Mean Difference (Final Values)0.937295% CI-0.3024 - 2.1767p0.1373Mixed Models Analysis
Mean Difference (Final Values)-4.639795% CI-5.8537 - -3.4257p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-4.445395% CI-5.6662 - -3.2244p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-4.357195% CI-5.5887 - -3.1255p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-6.243795% CI-7.4397 - -5.0477p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-6.049395% CI-7.2568 - -4.8419p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-5.961195% CI-7.1812 - -4.7410p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 42.1 | 18.77 |
| Alprazolam 1 mgn=33 Participants | 14.4 | 17.83 |
| Alprazolam 3 mgn=34 Participants | 8.6 | 9.36 |
| Dimebon 20 mgn=33 Participants | 42.9 | 21.32 |
| Dimebon 40 mgn=32 Participants | 37.7 | 21.32 |
| Dimebon 60 mgn=31 Participants | 38.5 | 16.10 |
Mean Difference (Final Values)-26.620595% CI-33.1192 - -20.1219p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-32.572495% CI-39.1073 - -26.0375p<0.0001Mixed Models Analysis
Mean Difference (Final Values)1.896695% CI-4.6607 - 8.4540p0.5685Mixed Models Analysis
Mean Difference (Final Values)-3.576195% CI-10.1590 - 3.0068p0.2848Mixed Models Analysis
Mean Difference (Final Values)-3.175495% CI-9.7855 - 3.4347p0.3440Mixed Models Analysis
Mean Difference (Final Values)28.517295% CI22.0454 - 34.9890p<0.0001Mixed Models Analysis
Mean Difference (Final Values)23.044595% CI16.5383 - 29.5506p<0.0001Mixed Models Analysis
Mean Difference (Final Values)23.445295% CI16.8772 - 30.0131p<0.0001Mixed Models Analysis
Mean Difference (Final Values)34.469095% CI28.1136 - 40.8244p<0.0001Mixed Models Analysis
Mean Difference (Final Values)28.996395% CI22.5734 - 35.4192p<0.0001Mixed Models Analysis
Mean Difference (Final Values)29.397095% CI22.8946 - 35.8994p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])
Time frame:0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| Placebon=32 Participants | 37.2 | 35.30 |
| Alprazolam 1 mgn=33 Participants | 84.0 | 23.27 |
| Alprazolam 3 mgn=34 Participants | 88.7 | 11.12 |
| Dimebon 20 mgn=33 Participants | 37.5 | 35.91 |
| Dimebon 40 mgn=32 Participants | 33.4 | 34.54 |
| Dimebon 60 mgn=31 Participants | 44.4 | 34.44 |
Mean Difference (Final Values)46.604495% CI33.4091 - 59.7996p<0.0001Mixed Models Analysis
Mean Difference (Final Values)50.722295% CI37.5038 - 63.9407p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-0.698795% CI-13.9815 - 12.5840p0.9174Mixed Models Analysis
Mean Difference (Final Values)-4.562995% CI-17.9006 - 8.7749p0.5002Mixed Models Analysis
Mean Difference (Final Values)6.398295% CI-7.0337 - 19.8301p0.3482Mixed Models Analysis
Mean Difference (Final Values)-47.303195% CI-60.4869 - -34.1193p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-51.167295% CI-64.4276 - -37.9069p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-40.206295% CI-53.5890 - -26.8234p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-51.421095% CI-64.3974 - -38.4445p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-55.285195% CI-68.3904 - -42.1798p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-44.324195% CI-57.5825 - -31.0656p<0.0001Mixed Models Analysis
Primary/registry result/low confidence
Other Subjective Effects- Drug Similarity
Time frame:12 hours post-dose
descriptive
Posted result
| Group | Value (mean), mm | Standard deviation |
|---|---|---|
| PlaceboPlacebo (n=32, 33, 34, 33, 32, 31)n=32 Participants | 56.3 | 42.65 |
| Benzodiazepines (n=23, 23, 25, 24, 22, 22)n=32 Participants | 51.0 | 38.99 |
| Codeine/Morphine (n=20, 20, 23, 22, 20, 20)n=32 Participants | 18.5 | 28.02 |
| THC (n=32, 33, 34, 33, 32, 31)n=32 Participants | 21.2 | 27.97 |
| Pseudoephedrine (n=6, 6, 6, 6, 7, 5)n=32 Participants | 21.8 | 33.42 |
| Alprazolam 1 mgPlacebo (n=32, 33, 34, 33, 32, 31)n=33 Participants | 10.2 | 22.20 |
| Benzodiazepines (n=23, 23, 25, 24, 22, 22)n=33 Participants | 88.6 | 21.87 |
| Codeine/Morphine (n=20, 20, 23, 22, 20, 20)n=33 Participants | 42.7 | 38.43 |
| THC (n=32, 33, 34, 33, 32, 31)n=33 Participants | 45.6 | 37.08 |
| Pseudoephedrine (n=6, 6, 6, 6, 7, 5)n=33 Participants | 21.5 | 27.70 |
| Alprazolam 3 mgPlacebo (n=32, 33, 34, 33, 32, 31)n=34 Participants | 4.0 | 12.27 |
| Benzodiazepines (n=23, 23, 25, 24, 22, 22)n=34 Participants | 92.7 | 20.66 |
| Codeine/Morphine (n=20, 20, 23, 22, 20, 20)n=34 Participants | 46.3 | 33.82 |
| THC (n=32, 33, 34, 33, 32, 31)n=34 Participants | 48.9 | 32.96 |
| Pseudoephedrine (n=6, 6, 6, 6, 7, 5)n=34 Participants | 66.5 | 12.14 |
| Dimebon 20 mgPlacebo (n=32, 33, 34, 33, 32, 31)n=33 Participants | 61.4 | 36.34 |
| Benzodiazepines (n=23, 23, 25, 24, 22, 22)n=33 Participants | 33.0 | 40.56 |
| Codeine/Morphine (n=20, 20, 23, 22, 20, 20)n=33 Participants | 14.7 | 28.49 |
| THC (n=32, 33, 34, 33, 32, 31)n=33 Participants | 21.9 | 30.44 |
| Pseudoephedrine (n=6, 6, 6, 6, 7, 5)n=33 Participants | 31.7 | 35.35 |
| Dimebon 40 mgPlacebo (n=32, 33, 34, 33, 32, 31)n=32 Participants | 57.8 | 43.15 |
| Benzodiazepines (n=23, 23, 25, 24, 22, 22)n=32 Participants | 42.6 | 40.81 |
| Codeine/Morphine (n=20, 20, 23, 22, 20, 20)n=32 Participants | 24.5 | 29.55 |
| THC (n=32, 33, 34, 33, 32, 31)n=32 Participants | 16.2 | 25.88 |
| Pseudoephedrine (n=6, 6, 6, 6, 7, 5)n=32 Participants | 30.7 | 28.89 |
| Dimebon 60 mgPlacebo (n=32, 33, 34, 33, 32, 31)n=31 Participants | 55.7 | 42.15 |
| Benzodiazepines (n=23, 23, 25, 24, 22, 22)n=31 Participants | 53.0 | 40.45 |
| Codeine/Morphine (n=20, 20, 23, 22, 20, 20)n=31 Participants | 28.2 | 29.66 |
| THC (n=32, 33, 34, 33, 32, 31)n=31 Participants | 25.3 | 31.56 |
| Pseudoephedrine (n=6, 6, 6, 6, 7, 5)n=31 Participants | 33.4 | 26.32 |
Mean Difference (Final Values)-46.382395% CI-62.1244 - -30.6401p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-51.519995% CI-67.2633 - -35.7765p<0.0001Mixed Models Analysis
Mean Difference (Final Values)6.036695% CI-9.7924 - 21.8657p0.4524Mixed Models Analysis
Mean Difference (Final Values)2.442395% CI-13.4599 - 18.3446p0.7620Mixed Models Analysis
Mean Difference (Final Values)0.157395% CI-15.8609 - 16.1754p0.9846Mixed Models Analysis
Mean Difference (Final Values)52.418995% CI36.7157 - 68.1221p<0.0001Mixed Models Analysis
Mean Difference (Final Values)48.824695% CI33.0228 - 64.6264p<0.0001Mixed Models Analysis
Mean Difference (Final Values)46.539595% CI30.5968 - 62.4823p<0.0001Mixed Models Analysis
Mean Difference (Final Values)57.556595% CI42.0679 - 73.0451p<0.0001Mixed Models Analysis
Mean Difference (Final Values)53.962295% CI38.3293 - 69.5952p<0.0001Mixed Models Analysis
Mean Difference (Final Values)51.677295% CI35.8660 - 67.4884p<0.0001Mixed Models Analysis
Mean Difference (Final Values)37.445495% CI17.7051 - 57.1857p0.0003Mixed Models Analysis
Mean Difference (Final Values)41.671495% CI22.2888 - 61.0540p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-17.758395% CI-37.2956 - 1.7789p0.0744Mixed Models Analysis
Mean Difference (Final Values)-9.555195% CI-29.5573 - 10.4471p0.3458Mixed Models Analysis
Mean Difference (Final Values)0.792095% CI-19.1777 - 20.7616p0.9375Mixed Models Analysis
Mean Difference (Final Values)-55.203795% CI-74.8113 - -35.5961p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-47.000595% CI-67.0020 - -26.9989p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-36.653495% CI-56.7246 - -16.5822p0.0004Mixed Models Analysis
Mean Difference (Final Values)-59.429795% CI-78.5162 - -40.3433p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-51.226595% CI-70.8131 - -31.6399p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-40.879495% CI-60.4726 - -21.2862p0.0001Mixed Models Analysis
Mean Difference (Final Values)23.519795% CI5.7096 - 41.3298p0.0102Mixed Models Analysis
Mean Difference (Final Values)27.732195% CI10.3632 - 45.1011p0.0021Mixed Models Analysis
Mean Difference (Final Values)-4.733495% CI-22.2807 - 12.8140p0.5935Mixed Models Analysis
Mean Difference (Final Values)3.548695% CI-14.3397 - 21.4370p0.6945Mixed Models Analysis
Mean Difference (Final Values)7.293695% CI-10.4975 - 25.0847p0.4177Mixed Models Analysis
Mean Difference (Final Values)-28.253195% CI-45.8020 - -10.7042p0.0019Mixed Models Analysis
Mean Difference (Final Values)-19.971195% CI-37.9541 - -1.9880p0.0299Mixed Models Analysis
Mean Difference (Final Values)-16.226195% CI-34.1785 - 1.7264p0.0759Mixed Models Analysis
Mean Difference (Final Values)-32.465595% CI-49.2278 - -15.7032p0.0002Mixed Models Analysis
Mean Difference (Final Values)-24.183595% CI-41.5832 - -6.7838p0.0069Mixed Models Analysis
Mean Difference (Final Values)-20.438595% CI-37.8861 - -2.9910p0.0222Mixed Models Analysis
Mean Difference (Final Values)24.589095% CI12.0126 - 37.1654p0.0002Mixed Models Analysis
Mean Difference (Final Values)29.110095% CI16.4903 - 41.7298p<0.0001Mixed Models Analysis
Mean Difference (Final Values)2.642895% CI-10.0309 - 15.3165p0.6809Mixed Models Analysis
Mean Difference (Final Values)-3.321595% CI-16.0415 - 9.3985p0.6067Mixed Models Analysis
Mean Difference (Final Values)5.472295% CI-7.3350 - 18.2795p0.3999Mixed Models Analysis
Mean Difference (Final Values)-21.946195% CI-34.5327 - -9.3596p0.0007Mixed Models Analysis
Mean Difference (Final Values)-27.910595% CI-40.5640 - -15.2570p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-19.116895% CI-31.8907 - -6.3428p0.0036Mixed Models Analysis
Mean Difference (Final Values)-26.467295% CI-38.8298 - -14.1046p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-32.431595% CI-44.9250 - -19.9380p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-23.637895% CI-36.2802 - -10.9954p0.0003Mixed Models Analysis
Mean Difference (Final Values)0.667595% CI-39.7080 - 41.0430p0.9728Mixed Models Analysis
Mean Difference (Final Values)42.797795% CI6.1059 - 79.4894p0.0246Mixed Models Analysis
Mean Difference (Final Values)7.541195% CI-33.7850 - 48.8672p0.7068Mixed Models Analysis
Mean Difference (Final Values)10.706995% CI-26.0358 - 47.4496p0.5492Mixed Models Analysis
Mean Difference (Final Values)11.124895% CI-31.3098 - 53.5595p0.5899Mixed Models Analysis
Mean Difference (Final Values)6.873695% CI-29.8691 - 43.6163p0.6998Mixed Models Analysis
Mean Difference (Final Values)10.039495% CI-31.4818 - 51.5606p0.6187Mixed Models Analysis
Mean Difference (Final Values)10.457395% CI-29.0355 - 49.9502p0.5863Mixed Models Analysis
Mean Difference (Final Values)-35.256695% CI-75.6080 - 5.0948p0.0832Mixed Models Analysis
Mean Difference (Final Values)-32.090795% CI-68.7519 - 4.5704p0.0827Mixed Models Analysis
Mean Difference (Final Values)-31.672895% CI-74.5352 - 11.1895p0.1386Mixed Models Analysis
Primary/registry result/low confidence
Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)
Time frame:0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
descriptive
Posted result
| Group | Value (mean), Units on Scale | Standard deviation |
|---|---|---|
| PlaceboEmaxn=32 Participants | 6.3 | 1.14 |
| Eminn=32 Participants | 4.8 | 1.90 |
| Alprazolam 1 mgEmaxn=33 Participants | 6.6 | 1.34 |
| Eminn=33 Participants | 2.5 | 2.05 |
| Alprazolam 3 mgEmaxn=34 Participants | 7.2 | 2.01 |
| Eminn=34 Participants | 1.7 | 1.31 |
| Dimebon 20 mgEmaxn=33 Participants | 6.5 | 1.72 |
| Eminn=33 Participants | 4.4 | 2.08 |
| Dimebon 40 mgEmaxn=32 Participants | 6.3 | 1.66 |
| Eminn=32 Participants | 4.7 | 1.72 |
| Dimebon 60 mgEmaxn=31 Participants | 6.4 | 1.38 |
| Eminn=31 Participants | 4.3 | 1.85 |
Mean Difference (Final Values)0.363795% CI-0.1566 - 0.8840p0.1691Mixed Models Analysis
Mean Difference (Final Values)0.844495% CI0.3238 - 1.3650p0.0017Mixed Models Analysis
Mean Difference (Final Values)0.209395% CI-0.3141 - 0.7327p0.4305Mixed Models Analysis
Mean Difference (Final Values)0.120695% CI-0.4064 - 0.6476p0.6517Mixed Models Analysis
Mean Difference (Final Values)-0.037495% CI-0.5666 - 0.4919p0.8892Mixed Models Analysis
Mean Difference (Final Values)-0.154495% CI-0.6737 - 0.3649p0.5576Mixed Models Analysis
Mean Difference (Final Values)-0.243195% CI-0.7658 - 0.2796p0.3594Mixed Models Analysis
Mean Difference (Final Values)-0.401195% CI-0.9291 - 0.1270p0.1355Mixed Models Analysis
Mean Difference (Final Values)-0.635195% CI-1.1466 - -0.1236p0.0153Mixed Models Analysis
Mean Difference (Final Values)-0.723895% CI-1.2418 - -0.2059p0.0065Mixed Models Analysis
Mean Difference (Final Values)-0.881895% CI-1.4042 - -0.3594p0.0011Mixed Models Analysis
Mean Difference (Final Values)-2.161495% CI-2.9373 - -1.3856p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-3.033695% CI-3.8085 - -2.2587p<0.0001Mixed Models Analysis
Mean Difference (Final Values)-0.279195% CI-1.0586 - 0.5004p0.4804Mixed Models Analysis
Mean Difference (Final Values)0.024095% CI-0.7608 - 0.8087p0.9519Mixed Models Analysis
Mean Difference (Final Values)-0.497095% CI-1.2860 - 0.2921p0.2152Mixed Models Analysis
Mean Difference (Final Values)1.882495% CI1.1094 - 2.6553p<0.0001Mixed Models Analysis
Mean Difference (Final Values)2.185495% CI1.4070 - 2.9638p<0.0001Mixed Models Analysis
Mean Difference (Final Values)1.664595% CI0.8786 - 2.4503p<0.0001Mixed Models Analysis
Mean Difference (Final Values)2.754595% CI1.9912 - 3.5179p<0.0001Mixed Models Analysis
Mean Difference (Final Values)3.057695% CI2.2858 - 3.8294p<0.0001Mixed Models Analysis
Mean Difference (Final Values)2.536695% CI1.7578 - 3.3155p<0.0001Mixed Models Analysis
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.